Thiamine Hydrochloride

Product NDC
50090-5407
Requested package NDC
50090-5407-1
11-digit product format
500905407
Labeler code
50090
Product ID
50090-5407_d3b9354d-0226-40ec-baa5-3df787a41803
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thiamine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA091623
Marketing category
ANDA
Marketing start
2013-06-04
Marketing end
0000-00-00
Substance
THIAMINE HYDROCHLORIDE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-540750090-5407-1IInactivated by FDA2026-08-10

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091623-001THIAMINE HYDROCHLORIDETHIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A091623-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-253f01610625f2…
2019-09-15 20:21 UTC2019-09A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091623-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2012-06-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091623-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091623-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091623-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091623-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091623-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091623-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091623-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091623-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091623-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091623-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091623-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091623-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091623-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091623-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091623-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091623-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091623-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091623-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091623-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091623-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091623-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A091623-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091623-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091623-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091623-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A091623-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091623-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091623-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091623-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091623-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091623-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091623-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091623-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091623-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091623-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091623-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091623-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091623-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091623-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091623-001AP1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5407-12023-01-30C16284748780-1f386c649-e003-0266-e053-dadaa90a7c1afc124280-c876-4d0a-b6f8-25921c0f78bb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5407-1Thiamine Hydrochloride2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5407THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20201215_fc124280-c876-4d0a-b6f8-25921c0f78bb.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THIAMINE HYDROCHLORIDETHIAMINE HYDROCHLORIDEHenry Schein, Inc.c006eca3-137a-493f-bbc4-f04e463d66f92025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091623
application number: ANDA091623
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEMylan Institutional LLC12986d0e-b8bf-4338-9d85-07f973b354392021-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091623
application number: ANDA091623

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313324thiamine hydrochloride 100 MG/ML Injectable SolutionPSNfc124280-c876-4d0a-b6f8-25921c0f78bb1
313324thiamine hydrochloride 100 MG/ML Injectable SolutionSCDfc124280-c876-4d0a-b6f8-25921c0f78bb1
313324vit-B1 hydrochloride 100 MG/ML Injectable SolutionSYfc124280-c876-4d0a-b6f8-25921c0f78bb1
313324vitamin B 1 100 MG/ML Injectable SolutionSYfc124280-c876-4d0a-b6f8-25921c0f78bb1
313324vitamin B1 hydrochloride 100 MG/ML Injectable SolutionSYfc124280-c876-4d0a-b6f8-25921c0f78bb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5407-1500905407012 mL in 1 VIAL, MULTI-DOSE (50090-5407-1) 2 ml2020-12-100000-00-00NoNoCurrent