Home NDC 83270-004 Thiamine Hydrochloride
Product NDC 83270-004
11-digit product format 832700004
Labeler code 83270
Product ID 83270-004_5268bd0e-2f42-cbeb-e063-6394a90a3ef8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Thiamine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler ONESOURCE SPECIALTY PHARMA LIMITED
Application ANDA217181
Marketing category ANDA
Marketing start 2026-02-27
Substance THIAMINE HYDROCHLORIDE
Active strength 100 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217181-001 THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217181-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A217181-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217181-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217181-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217181-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217181-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217181-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217181-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217181-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-10-29 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217181-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-10-29 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217181-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-10-29 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Thiamine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength THIAMINE HYDROCHLORIDE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M572600E5P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313324 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83270-004-01 Thiamine Hydrochloride 2 mL in 1 VIAL INJECTION, SOLUTION 2 3 83270-004-03 Thiamine Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83270-004 THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [ONESOURCE SPECIALTY PHARMA LIMITED] 2 Current NDC, 2 package rows 20250523_2e957a35-83b3-47f5-ad09-216b22cc30be.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83270-004-01 83270000401 2 mL in 1 VIAL 2 ml Historical 83270-004-03 83270000403 25 VIAL in 1 CARTON (83270-004-03) / 2 mL in 1 VIAL (83270-004-01) 25 vial 2026-02-27 No No Current