Home NDC 52584-196-00 THIAMINE HYDROCHLORIDE
Product NDC 52584-196
Requested package NDC 52584-196-00
11-digit product format 525840196
Labeler code 52584
Product ID 52584-196_af649b31-6818-45d4-8574-be0aafc66b83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name thiamine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler General Injectables & Vaccines, Inc
Application ANDA091623
Marketing category ANDA
Marketing start 2013-08-21
Marketing end 2023-08-31
Substance THIAMINE HYDROCHLORIDE
Active strength 100 mg/mL
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52584-196-00 52584019600 1 VIAL, MULTI-DOSE in 1 BAG (52584-196-00) > 2 mL in 1 VIAL, MULTI-DOSE 2013-08-21 2023-08-31 No No Current