Vitamin B Complex
Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide
Mylan Institutional Llc
Human Prescription Drug
NDC 67457-146Vitamin B Complex also known as Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide is a human prescription drug labeled by 'Mylan Institutional Llc'. National Drug Code (NDC) number for Vitamin B Complex is 67457-146. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Vitamin B Complex drug includes Dexpanthenol - 2 mg/mL Niacinamide - 100 mg/mL Pyridoxine Hydrochloride - 2 mg/mL Riboflavin 5'-phosphate Sodium - 2 mg/mL Thiamine Hydrochloride - 100 mg/mL . The currest status of Vitamin B Complex drug is Active.
Drug Information:
| Drug NDC: | 67457-146 |
| 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: | Vitamin B Complex |
| 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: | Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Mylan Institutional Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection |
| 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: | DEXPANTHENOL - 2 mg/mL
NIACINAMIDE - 100 mg/mL
PYRIDOXINE HYDROCHLORIDE - 2 mg/mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM - 2 mg/mL
THIAMINE HYDROCHLORIDE - 100 mg/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: | UNAPPROVED DRUG OTHER |
| 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: | 10 May, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 29 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. |
| 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: | Mylan Institutional LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 801177
|
| 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: | 1O6C93RI7Z
25X51I8RD4
68Y4CF58BV
20RD1DZH99
M572600E5P
|
| 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: | Analogs/Derivatives [Chemical/Ingredient]
Vitamin B 6 [Chemical/Ingredient]
Vitamin B6 Analog [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 |
|---|
| 67457-146-30 | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-146-30) / 30 mL in 1 VIAL, MULTI-DOSE | 10 May, 2013 | 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:
Vitamin b complex thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol and niacinamide thiamine hydrochloride thiamine ion thiamine riboflavin 5'-phosphate sodium flavin mononucleotide dexpanthenol dexpanthenol niacinamide niacinamide pyridoxine hydrochloride pyridoxine benzyl alcohol water hydrochloric acid sodium hydroxide
Indications and Usage:
Indications and usage in disorders requiring parenteral administration of vitamins, i.e. pre- and post-operative treatment, when requirements are increased as in fever, severe burns, increased metabolism, pregnancy, gastrointestinal disorders interfering with intake or absorption of vitamins, prolonged or wasting diseases, alcoholism and where other deficiencies exist.
Warnings:
Warnings anaphylactogenesis may occur with parenteral thiamine. use with caution. an intradermal test dose is recommended prior to administration in patients suspected of being sensitive to the drug.
Dosage and Administration:
Dosage and administration usually 0.25 to 2 ml by intramuscular or slow intravenous injection. high concentrations given intravenously may be diluted using parenteral infusion solutions. (see precautions .) parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit (see how supplied ).
Contraindications:
Contraindications sensitivity to the ingredients listed.
Adverse Reactions:
Adverse reactions mild transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching transitory exanthema, feeling of swelling of entire body, anaphylactic shock and death. sensitivity to the ingredients listed may occur (see warnings ). use should be discontinued upon observance of any untoward reaction. pain upon intramuscular injection may be noted.
Description:
Description vitamin b-complex 100 injection is a sterile solution for intramuscular or slow intravenous injection comprised of vitamins which may be categorized as belonging to the vitamin b complex group. each ml contains: thiamine hydrochloride 100 mg, riboflavin 5â phosphate sodium 2 mg, pyridoxine hydrochloride 2 mg, dexpanthenol 2 mg, niacinamide 100 mg, with benzyl alcohol 2% as preservative, in water for injection. sodium hydroxide and/or hydrochloric acid may have been used to adjust ph.
How Supplied:
How supplied vitamin b-complex 100 injection is available in a 30 ml multiple-dose vial individually boxed. phase separation due to reduced solubility can occur under certain conditions of shipping or storage (e.g. accidental freezing), which may produce visible particles. do not use product if these do not redissolve on warming to body temperature and shaking well. refrigeration of the product may cause darkening of the solution due to the riboflavin content. the colour does not affect the safety or efficacy of the product. protect from light: store in carton until contents are used. store under refrigeration 2° to 8°c (36° to 46°f). do not permit to freeze. manufactured for: mylan institutional llc morgantown, wv 26505 u.s.a. manufactured by: mylan institutional galway, ireland 0415l107 revised: 9/2021 mi:vitbij:r4
Package Label Principal Display Panel:
Principal display panel - 30 ml ndc 67457-146-30 30 ml vitamin b-complex 100 injection for intramuscular or slow intravenous use rx only multi-dose vial sterile each ml contains: thiamine hcl 100 mg, riboflavin 5' phosphate sodium 2 mg, pyridoxine hcl 2 mg, dexpanthenol 2 mg, niacinamide 100 mg, with benzyl alcohol 2% as preservative, in water for injection. sodium hydroxide and/or hydrochloric acid may have been used to adjust ph. warning: anaphylactogenesis to parenteral thiamine has been reported. use with caution. usual dosage: see accompanying prescribing information. store under refrigeration 2° to 8°c (36° to 46°f). do not freeze. protect from light. store in carton until contents are used. manufactured for: mylan institutional llc morgantown, wv 26505 u.s.a. manufactured by: mylan institutional galway, ireland mi:146:1c:r4 mylan.com vitamin b-complex 100 injection carton label