Cyanocobalamin
Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-044Cyanocobalamin is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Cyanocobalamin is 63323-044. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Cyanocobalamin drug includes Cyanocobalamin - 1000 ug/mL . The currest status of Cyanocobalamin drug is Active.
Drug Information:
| Drug NDC: | 63323-044 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cyanocobalamin |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Cyanocobalamin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Fresenius Kabi Usa, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CYANOCOBALAMIN - 1000 ug/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
SUBCUTANEOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 18 Oct, 2000 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA080557 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Fresenius Kabi USA, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 309594
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | M0022794
N0000175951
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | P6YC3EG204
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Vitamin B12 [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Vitamin B 12 [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Vitamin B 12 [CS]
Vitamin B12 [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63323-044-01 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-01) / 1 mL in 1 VIAL, MULTI-DOSE (63323-044-00) | 18 Oct, 2000 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Cyanocobalamin cyanocobalamin cyanocobalamin cyanocobalamin sodium chloride benzyl alcohol sodium hydroxide hydrochloric acid
Indications and Usage:
Indications and usage cyanocobalamin is indicated for vitamin b 12 deficiencies due to malabsorption which may be associated with the following conditions: addisonian (pernicious) anemia gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy fish tapeworm infestation malignancy of pancreas or bowel folic acid deficiency it may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see drug/laboratory test interactions ), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. such measures remove the need for long-term administration of cyanocobalamin. requirements of vitamin b 12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic
Read more... and renal disease) can usually be met with oral supplementation. cyanocobalamin injection is also suitable for the vitamin b 12 absorption test (schilling test).
Warnings:
Warnings warning: this product contains aluminum that may be toxic. aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. tissue loading may occur at even lower rates of administration. patients with early leberâs disease (hereditary optic nerve atrophy) who were treated with cyanocobalamin suffered severe and swift optic atrophy. hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely. anaphylactic shock and death have been reported after parenteral vitamin b 12 admini
Read more...stration. an intradermal test dose is recommended before cyanocobalamin injection is administered to patients suspected of being sensitive to this drug. this product contains benzyl alcohol. benzyl alcohol has been reported to be associated with a fatal ââgasping syndromeââ in premature infants.
Dosage and Administration:
Dosage and administration avoid using the intravenous route. use of this product intravenously will result in almost all of the vitamin being lost in the urine. pernicious anemia parenteral vitamin b 12 is the recommended treatment and will be required for the remainder of the patientâs life. the oral form is not dependable. a dose of 100 mcg daily for six or seven days should be administered by intramuscular or deep subcutaneous injection. if there is clinical improvement and if a reticulocyte response is observed, the same amount may be given on alternate days for seven doses, then every three to four days for another two to three weeks. by this time hematologic values should have become normal. this regimen should be followed by 100 mcg monthly for life. folic acid should be administered concomitantly if needed. patients with normal intestinal absorption where the oral route is not deemed adequate, initial treatment similar to that for patients with pernicious anemia may be ind
Read more...icated depending on the severity of the deficiency. chronic treatment should be with an oral b 12 preparation. if other vitamin deficiencies are present, they should be treated. schilling test the flushing dose is 1000 mcg. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Pernicious anemia parenteral vitamin b 12 is the recommended treatment and will be required for the remainder of the patientâs life. the oral form is not dependable. a dose of 100 mcg daily for six or seven days should be administered by intramuscular or deep subcutaneous injection. if there is clinical improvement and if a reticulocyte response is observed, the same amount may be given on alternate days for seven doses, then every three to four days for another two to three weeks. by this time hematologic values should have become normal. this regimen should be followed by 100 mcg monthly for life. folic acid should be administered concomitantly if needed.
Patients with normal intestinal absorption where the oral route is not deemed adequate, initial treatment similar to that for patients with pernicious anemia may be indicated depending on the severity of the deficiency. chronic treatment should be with an oral b 12 preparation. if other vitamin deficiencies are present, they should be treated.
Schilling test the flushing dose is 1000 mcg. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications:
Contraindications sensitivity to cobalt and/or vitamin b 12 is a contraindication.
Adverse Reactions:
Adverse reactions generalized anaphylactic shock and death have been reported with administration of parenteral vitamin b 12 (see warnings ). cardiovascular pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis. hematological polycythemia vera. gastrointestinal mild transient diarrhea. dermatological itching; transitory exanthema. miscellaneous feeling of swelling of entire body.
Generalized anaphylactic shock and death have been reported with administration of parenteral vitamin b 12 (see warnings ).
Cardiovascular pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis.
Hematological polycythemia vera.
Gastrointestinal mild transient diarrhea.
Dermatological itching; transitory exanthema.
Miscellaneous feeling of swelling of entire body.
Overdosage:
Overdosage no overdosage has been reported with this drug.
Description:
Description cyanocobalamin injection, usp is a sterile solution of cyanocobalamin for intramuscular or subcutaneous use. each ml contains 1000 mcg cyanocobalamin; sodium chloride 0.9%; benzyl alcohol 1.5%; water for injection q.s. hydrochloric acid and/or sodium hydroxide for ph adjustment if necessary (4.5-7.0). cyanocobalamin appears as dark, red crystals or as an amorphous or crystalline, red powder. it is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). it is stable to autoclaving for short periods at 121°c. the vitamin b 12 coenzymes are very unstable in light. the chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide. the cobalt content is 4.34%. the structural formula is represented below: structure
Clinical Pharmacology:
Clinical pharmacology vitamin b 12 is essential to growth, cell reproduction, hematopoiesis, nucleoprotein and myelin synthesis. cyanocobalamin is quantitatively and rapidly absorbed from intramuscular and subcutaneous sites of injection; the plasma level of the compound reaches its peak within one hour after intramuscular injection. absorbed vitamin b 12 is transported via specific b 12 binding proteins, transcobalamin i and ii to the various tissues. the liver is the main organ for vitamin b 12 storage. within 48 hours after injection of 100 or 1000 mcg of vitamin b 12 , 50 to 98% of the injected dose may appear in the urine. the major portion is excreted within the first eight hours. intravenous administration results in even more rapid excretion with little opportunity for liver storage. gastrointestinal absorption of vitamin b 12 depends on the presence of sufficient intrinsic factor and calcium ions. intrinsic factor deficiency causes pernicious anemia, which may be associated wi
Read more...th subacute combined degeneration of the spinal cord. prompt parenteral administration of vitamin b 12 prevents progression of neurologic damage. the average diet supplies about 5 to 15 mcg/day of vitamin b 12 in a protein-bound form that is available for absorption after normal digestion. vitamin b 12 is not present in foods of plant origin, but is abundant in foods of animal origin. in people with normal absorption, deficiencies have been reported only in strict vegetarians who consume no products of animal origin (including no milk products or eggs). vitamin b 12 is bound to intrinsic factor during transit through the stomach; separation occurs in the terminal ileum in the presence of calcium, and vitamin b 12 enters the mucosal cell for absorption. it is then transported by the transcobalamin binding proteins. a small amount (approximately 1% of the total amount ingested) is absorbed by simple diffusion, but this mechanism is adequate only with very large doses. oral absorption is considered too undependable to rely on in patients with pernicious anemia or other conditions resulting in malabsorption of vitamin b 12 . cyanocobalamin is the most widely used form of vitamin b 12 , and has hematopoietic activity apparently identical to that of the antianemia factor in purified liver extract. hydroxocobalamin is equally as effective as cyanocobalamin, and they share the cobalamin molecular structure.
How Supplied:
How supplied cyanocobalamin injection, usp is supplied as follows: product code unit of sale strength each 4401 ndc 63323-044-01 unit of 25 1,000 mcg per ml 1 ml fill in a 2 ml vial ndc 63323-044-00 1 ml multiple dose vial store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from light. use only if solution is clear and seal intact.
Package Label Principal Display Panel:
Package label - principal display - cyanocobalamin 1 ml multiple dose vial label ndc 63323-044-00 4401 cyanocobalamin injection, usp 1,000 mcg/ml for im or sc use 1 ml multiple dose vial protect from light. rx only package label - principal display - cyanocobalamin 1 ml multiple dose vial tray label ndc 63323-044-01 4401 cyanocobalamin injection, usp 1,000 mcg/ml for im or sc use 25 x 1 ml multiple dose vials rx only vial tray