Thiamine

Product NDC: 50090-4407
Requested package NDC: 50090-4407-1
11-digit product format: 500904407
Labeler code: 50090
Product ID: 50090-4407_e13f0b60-4212-4402-9b33-fdb28b51d569
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: THIAMINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: A-S Medication Solutions
Application: ANDA080556
Marketing category: ANDA
Marketing start: 2000-09-01
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4407	50090-4407-1	I	Inactivated by FDA		2026-08-11

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 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080556-001	THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A080556-001	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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080556-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080556-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080556-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080556-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080556-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080556-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080556-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080556-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080556-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080556-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080556-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080556-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080556-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080556-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080556-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080556-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080556-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080556-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080556-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080556-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080556-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080556-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080556-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080556-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080556-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080556-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080556-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080556-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080556-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080556-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080556-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080556-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080556-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080556-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080556-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080556-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080556-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080556-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080556-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080556-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080556-001	AP	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cf050ccd-1144-f76a-e00d-e5698d8597d4	Product name	6	20250625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4407-1	2023-01-30	C162847	48780-1	f386c64a-2ce5-0266-e053-dadaa90a7c1a	Thiamine Hydrochloride Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4407-1	Thiamine	1 in 1 BAG	INJECTION, SOLUTION	1		4
50090-4407-1	Thiamine	2 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	2		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4407-1	ML - Milliliter	50090-4407	87e6f99d-32b7-4884-a5b0-29cb922e6354	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4407	THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]	4	Legacy NDC, 2 package rows	20200714_1a8ee45b-784c-4b90-aae2-f88d43ab771b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Thiamine	THIAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	c3c9db74-95d4-487c-90c3-c810786fbaec	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080556 application number: ANDA080556
Thiamine	THIAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ca4899c6-cea1-48d6-b0ae-9efcf67f6fcb	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080556 application number: ANDA080556
Thiamine	THIAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	af3f9344-f743-4bad-b319-53b96e13fee2	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080556 application number: ANDA080556
THIAMINE HCl	THIAMINE HCL	HF Acquisition Co LLC, DBA HealthFirst	c4c436ab-cbb7-9429-e053-2995a90a58ae	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080556 application number: ANDA080556

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M572600E5P	THIAMINE HYDROCHLORIDE	67-03-8	THIAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313324	thiamine hydrochloride 100 MG/ML Injectable Solution	PSN	1a8ee45b-784c-4b90-aae2-f88d43ab771b	4
313324	thiamine hydrochloride 100 MG/ML Injectable Solution	SCD	1a8ee45b-784c-4b90-aae2-f88d43ab771b	4
313324	vit-B1 hydrochloride 100 MG/ML Injectable Solution	SY	1a8ee45b-784c-4b90-aae2-f88d43ab771b	4
313324	vitamin B 1 100 MG/ML Injectable Solution	SY	1a8ee45b-784c-4b90-aae2-f88d43ab771b	4
313324	vitamin B1 hydrochloride 100 MG/ML Injectable Solution	SY	1a8ee45b-784c-4b90-aae2-f88d43ab771b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4407-1	50090440701	1 VIAL, MULTI-DOSE in 1 BAG (50090-4407-1) > 2 mL in 1 VIAL, MULTI-DOSE	2019-07-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Thiamine Hydrochloride Injection, USP	A-S Medication Solutions	2020-07-13	HUMAN PRESCRIPTION DRUG LABEL	4