thiamine

Generic: thiamine hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name thiamine
Generic Name thiamine hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

thiamine hydrochloride 100 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-013
Product ID 63323-013_99612c11-05be-4741-8b1d-0900165ef943
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080556
Listing Expiration 2027-12-31
Marketing Start 2000-09-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323013
Hyphenated Format 63323-013

Supplemental Identifiers

RxCUI
313324
UPC
0363323013417
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 (source: ndc)
Generic Name thiamine hydrochloride (source: ndc)
Application Number ANDA080556 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 TRAY (63323-013-26) / 2 mL in 1 VIAL, MULTI-DOSE (63323-013-41)
source: ndc

Packages (1)

63323-013-26 25 VIAL, MULTI-DOSE in 1 TRAY (63323-013-26) / 2 mL in 1 VIAL, MULTI-DOSE (63323-013-41)

Ingredients (1)

thiamine hydrochloride (100 mg/mL)

Linked Drug Pages (3)

Thiamine ndc-match (0.9) Thiamine ndc-match (0.9) Thiamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "99612c11-05be-4741-8b1d-0900165ef943", "openfda": {"upc": ["0363323013417"], "unii": ["M572600E5P"], "rxcui": ["313324"], "spl_set_id": ["af3f9344-f743-4bad-b319-53b96e13fee2"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-013-26)  / 2 mL in 1 VIAL, MULTI-DOSE (63323-013-41)", "package_ndc": "63323-013-26", "marketing_start_date": "20000901"}], "brand_name": "Thiamine", "product_id": "63323-013_99612c11-05be-4741-8b1d-0900165ef943", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "63323-013", "generic_name": "THIAMINE HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Thiamine", "active_ingredients": [{"name": "THIAMINE HYDROCHLORIDE", "strength": "100 mg/mL"}], "application_number": "ANDA080556", "marketing_category": "ANDA", "marketing_start_date": "20000901", "listing_expiration_date": "20271231"}