thiamine hydrochloride

Generic: thiamine hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name thiamine hydrochloride
Generic Name thiamine hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

thiamine hydrochloride 200 mg/2mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-567
Product ID 68083-567_809c6495-dfc8-4a9e-ab98-9a5e607075ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217800
Listing Expiration 2026-12-31
Marketing Start 2025-02-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083567
Hyphenated Format 68083-567

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 ANDA217800 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/2mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (68083-567-25) / 2 mL in 1 VIAL
source: ndc

Packages (1)

68083-567-25 25 VIAL in 1 CARTON (68083-567-25) / 2 mL in 1 VIAL

Ingredients (1)

thiamine hydrochloride (200 mg/2mL)

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": "809c6495-dfc8-4a9e-ab98-9a5e607075ab", "openfda": {"unii": ["M572600E5P"], "rxcui": ["313324"], "spl_set_id": ["fc0265cd-d13a-477c-8c2c-8d44fd86444e"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (68083-567-25)  / 2 mL in 1 VIAL", "package_ndc": "68083-567-25", "marketing_start_date": "20250224"}], "brand_name": "thiamine hydrochloride", "product_id": "68083-567_809c6495-dfc8-4a9e-ab98-9a5e607075ab", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "68083-567", "generic_name": "thiamine hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "thiamine hydrochloride", "active_ingredients": [{"name": "THIAMINE HYDROCHLORIDE", "strength": "200 mg/2mL"}], "application_number": "ANDA217800", "marketing_category": "ANDA", "marketing_start_date": "20250224", "listing_expiration_date": "20261231"}