Home NDC 67457-196 Thiamine Hydrochloride
Product NDC 67457-196
11-digit product format 674570196
Labeler code 67457
Product ID 67457-196_cbc5513d-4341-455c-b435-53dd5624efaa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name thiamine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA091623
Marketing category ANDA
Marketing start 2013-06-04
Substance THIAMINE HYDROCHLORIDE
Active strength 100 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 2026-02-19 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091623-001 THIAMINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2012-06-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Thiamine Hydrochloride
Listing expiration 2026-12-31 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 67457-196-00 Thiamine Hydrochloride 2 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 2 8 67457-196-02 Thiamine Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Thiamine Hydrochloride ACTIVE INGREDIENT M572600E5P THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 3 THIAMINE ION ACTIVE MOIETY 4ABT0J945J THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 3 MONOTHIOGLYCEROL INACTIVE INGREDIENT AAO1P0WSXJ THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 3 Sodium hydroxide INACTIVE INGREDIENT 55X04QC32I THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 3 Water INACTIVE INGREDIENT 059QF0KO0R THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 3 THIAMINE HYDROCHLORIDE ACTIVE INGREDIENT M572600E5P THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 1 THIAMINE ION ACTIVE MOIETY 4ABT0J945J THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 1 MONOTHIOGLYCEROL INACTIVE INGREDIENT AAO1P0WSXJ THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-196 THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 8 Current NDC, Legacy NDC, 2 package rows 20210616_12986d0e-b8bf-4338-9d85-07f973b35439.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 Units Marketing start Marketing end Sample Exclude flag Status 67457-196-00 67457019600 2 mL in 1 VIAL, MULTI-DOSE 2 ml Historical 67457-196-02 67457019602 25 VIAL, MULTI-DOSE in 1 CARTON (67457-196-02) / 2 mL in 1 VIAL, MULTI-DOSE (67457-196-00) 2013-06-04 0000-00-00 No No Current