Chromium
Chromic Chloride
Hospira, Inc.
Human Prescription Drug
NDC 0409-4093Chromium also known as Chromic Chloride is a human prescription drug labeled by 'Hospira, Inc.'. National Drug Code (NDC) number for Chromium is 0409-4093. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Chromium drug includes Chromic Chloride - 4 ug/mL . The currest status of Chromium drug is Active.
Drug Information:
| Drug NDC: | 0409-4093 |
| 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: | Chromium |
| 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: | Chromic Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hospira, Inc. |
| 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: | CHROMIC CHLORIDE - 4 ug/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| 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: | NDA |
| 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: | 30 Jun, 2005 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 02 Jan, 2026 |
| 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: | NDA018961 |
| 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: | Hospira, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 204401
|
| 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. |
| UNII: | KB1PCR9DMW
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0409-4093-01 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4093-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-4093-11) | 30 Jun, 2005 | 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:
Chromium chromic chloride chromic chloride chromic cation sodium chloride hydrochloric acid sodium hydroxide
Indications and Usage:
Indications and usage chromium 4 mcg/ml (chromic chloride injection, usp) is indicated for use as a supplement to intravenous solutions given for tpn. administration helps to maintain chromium serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
Warnings:
Warnings direct intramuscular or intravenous injection of chromium 4 mcg/ml (chromic chloride injection, usp) is contraindicated, as the acidic ph of the solution may cause considerable tissue irritation. severe kidney disease may make it necessary to reduce or omit chromium and zinc doses because these elements are primarily eliminated in the urine. 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 admini
Read more...stration.
General Precautions:
General do not use unless solution is clear and seal is intact. chromium 4 mcg/ml (chromic chloride injection, usp) should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. solution contains no preservatives; discard unused portion immediately after admixture procedure is completed. in assessing the contribution of chromium supplements to maintenance of glucose homeostasis, consideration should be given to the possibility that the patient may be diabetic.
Dosage and Administration:
Dosage and administration chromium 4 mcg/ml (chromic chloride injection, usp) contains 4 mcg chromium/ml and is administered intravenously only after dilution. the additive should be administered in a volume of fluid not less than 100 ml. for the adult receiving tpn, the suggested additive dosage is 10 to 15 mcg chromium/day (2.5 to 3.75 ml/day). the metabolically stable adult with intestinal fluid loss may require 20 mcg chromium/day (5 ml/day), with frequent monitoring of blood levels as a guideline for subsequent administration. for pediatric patients, the suggested additive dosage is 0.14 to 0.20 mcg/kg/day (0.035 to 0.05 ml/kg/day). parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions .
Contraindications:
Contraindications none known.
Adverse Reactions:
Adverse reactions none known.
Use in Pregnancy:
Pregnancy animal reproduction studies have not been conducted with chromic chloride. it is also not known whether chromic chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. chromic chloride should be given to a pregnant woman only if clearly indicated.
Pediatric Use:
Pediatric use see dosage and administration section. safety and effectiveness in children have not been established.
Geriatric Use:
Geriatric use an evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Overdosage:
Overdosage trivalent chromium administered intravenously to tpn patients has been shown to be nontoxic when given at dosage levels of up to 250 mcg/day for two consecutive weeks. reported toxic reactions to chromium include nausea, vomiting, ulcers of the gastrointestinal tract, renal and hepatic damage, convulsions and coma. the acute ld 50 for intravenous trivalent chromium in rats was reported as 10 to 18 mg/kg.
Description:
Description chromium 4 mcg/ml (chromic chloride injection, usp) is a sterile, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition (tpn). each ml of solution contains 20.5 mcg chromic chloride, hexahydrate and 9 mg sodium chloride. the solution contains no bacteriostat, antimicrobial agent, or added buffer. the ph is 2.0 (1.5 to 2.5); product may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. the osmolarity is 0.308 mosm/ml (calc.). chromic chloride, usp is chemically designated chromic chloride, hexahydrate crcl 3 ⢠6h 2 o, a crystalline compound soluble in water. sodium chloride, usp is chemically designated nacl, a white, crystalline compound freely soluble in water. the semi-rigid vial is fabricated from a specially formulated polyolefin. it is a copolymer of ethylene and propylene. the safety of the plastic has been confirmed by tests in animals according to usp biological standards for plastic containers. the small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration.
Clinical Pharmacology:
Clinical pharmacology trivalent chromium is part of glucose tolerance factor, an essential activator of insulin-mediated reactions. chromium helps to maintain normal glucose metabolism and peripheral nerve function. providing chromium during tpn helps prevent deficiency symptoms including impaired glucose tolerance, ataxia, peripheral neuropathy and a confusional state similar to mild/moderate hepatic encephalopathy. serum chromium is bound to transferrin (siderophilin) in the beta globulin fraction. typical blood levels for chromium range from 1 to 5 mcg/liter, but blood levels are not considered a meaningful index of tissue stores. administration of chromium supplements to chromium-deficient patients can result in normalization of the glucose tolerance curve from the diabetic-like curve typical of chromium deficiency. this response is viewed as a more meaningful indicator of chromium nutriture than serum chromium levels. excretion of chromium is via the kidneys, ranging from 3 to 50
Read more...mcg/day. biliary excretion via the small intestine may be an ancillary route, but only small amounts of chromium are believed to be excreted in this manner.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, and impairment of fertility long-term animal studies to evaluate the carcinogenic potential of chromium 4 mcg/ml (chromic chloride injection, usp) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.
How Supplied:
How supplied chromium (chromic chloride injection, usp) is supplied as follows: unit of sale concentration ndc 0409-4093-01 40 mcg/10 ml tray of 25 single-dose plastic vials (4 mcg/ml) store at 20 to 25ºc (68 to 77ºf). [see usp controlled room temperature.] distributed by hospira, inc., lake forest, il 60045 usa lab-1065-3.0 revised: 4/2021 hospira logo
Package Label Principal Display Panel:
Principal display panel - 10 ml vial label 10 ml single-dose vial chromium chromic chloride inj., usp 40 mcg/10 ml (4 mcg/ml) distributed by hospira, inc., lake forest, il 60045 usa hospira principal display panel - 10 ml vial label
Principal display panel - 10 ml vial tray 10 ml single-dose vial rx only ndc 0409-4093-01 contains 25 of ndc 0409-4093-11 chromium chromic chloride injection, usp 40 mcg/10 ml (4 mcg/ml) caution: for intravenous use only after dilution. hospira principal display panel - 10 ml vial tray