thiamine hydrochloride

Generic: thiamine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name thiamine hydrochloride
Generic Name thiamine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

thiamine hydrochloride 100 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6228
Product ID 0641-6228_54a057cd-6e3d-40e6-8329-98e47da7dd68
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080575
Listing Expiration 2026-12-31
Marketing Start 2021-02-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416228
Hyphenated Format 0641-6228

Supplemental Identifiers

RxCUI
313324
UNII
M572600E5P

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name thiamine hydrochloride (source: ndc)
Generic Name thiamine hydrochloride (source: ndc)
Application Number ANDA080575 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0641-6228-25) / 2 mL in 1 VIAL (0641-6228-01)
source: ndc

Packages (1)

0641-6228-25 25 VIAL in 1 CARTON (0641-6228-25) / 2 mL in 1 VIAL (0641-6228-01)

Ingredients (1)

thiamine hydrochloride (100 mg/mL)

Linked Drug Pages (1)

Thiamine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "54a057cd-6e3d-40e6-8329-98e47da7dd68", "openfda": {"unii": ["M572600E5P"], "rxcui": ["313324"], "spl_set_id": ["63f3631b-ba1e-430c-a30b-dd05b2c00c13"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0641-6228-25)  / 2 mL in 1 VIAL (0641-6228-01)", "package_ndc": "0641-6228-25", "marketing_start_date": "20210212"}], "brand_name": "Thiamine Hydrochloride", "product_id": "0641-6228_54a057cd-6e3d-40e6-8329-98e47da7dd68", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0641-6228", "generic_name": "Thiamine Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Thiamine Hydrochloride", "active_ingredients": [{"name": "THIAMINE HYDROCHLORIDE", "strength": "100 mg/mL"}], "application_number": "ANDA080575", "marketing_category": "ANDA", "marketing_start_date": "20210212", "listing_expiration_date": "20261231"}