Thiamine Hydrochloride

Product NDC: 72266-260
11-digit product format: 722660260
Labeler code: 72266
Product ID: 72266-260_3649f758-e30e-3c6a-e063-6294a90a5c36
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Thiamine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fosun Pharma USA Inc.
Application: ANDA217181
Marketing category: ANDA
Marketing start: 2026-02-02
Substance: THIAMINE HYDROCHLORIDE
Active strength: 100 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A217181-001	THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP		2024-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217181-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217181-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	2024-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217181-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	2024-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217181-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	2024-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217181-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	2024-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217181-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	2024-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217181-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	2024-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217181-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	2024-10-29	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217181-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	2024-10-29	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217181-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	2024-10-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217181-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217181-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217181-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217181-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217181-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217181-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217181-001	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217181-001	AP	1	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217181-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Thiamine Hydrochloride
Listing expiration: 2027-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3649f7b5-dcce-b246-e063-6394a90a3145	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72266-260-01	Thiamine Hydrochloride	2 mL in 1 VIAL	INJECTION, SOLUTION	2		1
72266-260-25	Thiamine Hydrochloride	25 in 1 CARTON	INJECTION, SOLUTION	25		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72266-260-01	ML - Milliliter	72266-260	0d84c3b1-5ef5-49db-957d-8d7e2a2db3cf	1	2026-02-05
72266-260-25	ML - Milliliter	72266-260	96a6ca46-15ab-4c6f-a204-80bb1bae2049	1	2026-02-05

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Thiamine Hydrochloride	THIAMINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	764d608a-d821-4447-85e1-6af297abb4c1	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217181 application number: ANDA217181
Thiamine Hydrochloride	THIAMINE HYDROCHLORIDE	ONESOURCE SPECIALTY PHARMA LIMITED	2e957a35-83b3-47f5-ad09-216b22cc30be	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217181 application number: ANDA217181
Thiamine Hydrochloride	THIAMINE HYDROCHLORIDE	Fosun Pharma USA Inc.	3649f7b5-dcce-b246-e063-6394a90a3145	2025-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217181 application number: ANDA217181 ndc (product): 72266-260

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	3649f7b5-dcce-b246-e063-6394a90a3145	1
313324	thiamine hydrochloride 100 MG/ML Injectable Solution	SCD	3649f7b5-dcce-b246-e063-6394a90a3145	1
313324	vit-B1 hydrochloride 100 MG/ML Injectable Solution	SY	3649f7b5-dcce-b246-e063-6394a90a3145	1
313324	vitamin B 1 100 MG/ML Injectable Solution	SY	3649f7b5-dcce-b246-e063-6394a90a3145	1
313324	vitamin B1 hydrochloride 100 MG/ML Injectable Solution	SY	3649f7b5-dcce-b246-e063-6394a90a3145	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72266-260-01	72266026001	2 mL in 1 VIAL	2 ml				Historical
72266-260-25	72266026025	25 VIAL in 1 CARTON (72266-260-25) / 2 mL in 1 VIAL (72266-260-01)	25 vial	2026-02-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Thiamine Hydrochloride Injection, USP Rx only	Fosun Pharma USA Inc.	2025-06-29	HUMAN PRESCRIPTION DRUG LABEL	1