Application 080556

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/ML	No	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
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…`

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 ndc (product): 63323-013
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 ndc (product): 63323-013
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 ndc (product): 63323-013
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 ndc (product): 51662-1523

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4407	Thiamine	THIAMINE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-4407	Thiamine	THIAMINE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
51662-1523	THIAMINE HCl	THIAMINE HCl	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1523	THIAMINE HCl	THIAMINE HCl	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
55154-9372	Thiamine	THIAMINE HYDROCHLORIDE	Cardinal Health	ANDA	Current
63323-013	Thiamine	THIAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-013	Thiamine	THIAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-013	Thiamine	THIAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-013	Thiamine	THIAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-013	Thiamine	THIAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-013	Thiamine	THIAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-013	Thiamine	THIAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current