Home NDC 0404-9963 THIAMINE HYDROCHLORIDE
Product NDC 0404-9963
11-digit product format 004049963
Labeler code 0404
Product ID 0404-9963_cf11a7a8-2864-4682-a335-71cc5591bc48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name thiamine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA091623
Marketing category ANDA
Marketing start 2022-01-12
Marketing end 2026-11-30
Substance THIAMINE HYDROCHLORIDE
Active strength 100 mg/mL
NDC exclude flag No
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 A091623-001 THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091623-001 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.
Product history page 1 of 2 · 42 observed 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 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base THIAMINE HYDROCHLORIDE 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 0404-9963-02 THIAMINE HYDROCHLORIDE 1 in 1 BAG INJECTION, SOLUTION 1 6 0404-9963-02 THIAMINE HYDROCHLORIDE 2 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9963 THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240704_c006eca3-137a-493f-bbc4-f04e463d66f9.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0404-9963-02 00404996302 1 VIAL, MULTI-DOSE in 1 BAG (0404-9963-02) / 2 mL in 1 VIAL, MULTI-DOSE 2022-01-12 2026-11-30 No No Current