Application 087954

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VITAMIN K1	PHYTONADIONE	INJECTABLE;INJECTION	1MG/0.5ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A087954-001	VITAMIN K1	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087954-001	BP

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 · 42 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
2026-08-18 06:07:40	2026-07	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS	1983-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS	1983-07-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS	1983-07-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS	1983-07-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS	1983-07-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS	1983-07-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS	1983-07-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RS	1983-07-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087954-001	VITAMIN K1	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS	1983-07-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A087954-001	BP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087954-001	BP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087954-001	BP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087954-001	BP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087954-001	BP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087954-001	BP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087954-001	BP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087954-001	BP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087954-001	BP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087954-001	BP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087954-001	BP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087954-001	BP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087954-001	BP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087954-001	BP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087954-001	BP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087954-001	BP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087954-001	BP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087954-001	BP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087954-001	BP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087954-001	BP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087954-001	BP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087954-001	BP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087954-001	BP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087954-001	BP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087954-001	BP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087954-001	BP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087954-001	BP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087954-001	BP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087954-001	BP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087954-001	BP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087954-001	BP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087954-001	BP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087954-001	BP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087954-001	BP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087954-001	BP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087954-001	BP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087954-001	BP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087954-001	BP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087954-001	BP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087954-001	BP	1	`e64feba35796…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vitamin K1	PHYTONADIONE	Hospira, Inc.	e8808230-2c44-44c6-8cab-8f29b6b34051	2026-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087954 application number: ANDA087954 ndc (product): 0409-9157
VITAMIN K1 PHYTONADIONE	VITAMIN K1, PHYTONADIONE	HF Acquisition Co LLC, DBA HealthFirst	cfc0df9f-ee59-9e30-e053-2995a90ad449	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087954 application number: ANDA087954 ndc (product): 51662-1537

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
0409-9157	Vitamin K1	PHYTONADIONE	Hospira, Inc.	ANDA	Current
0409-9157	Vitamin K1	PHYTONADIONE	Hospira, Inc.	ANDA	Current
0409-9157	Vitamin K1	PHYTONADIONE	Hospira, Inc.	ANDA	Current
0409-9157	Vitamin K1	PHYTONADIONE	Hospira, Inc.	ANDA	Current
0409-9157	Vitamin K1	PHYTONADIONE	Hospira, Inc.	ANDA	Current
0409-9157	Vitamin K1	PHYTONADIONE	Hospira, Inc.	ANDA	Current
50090-4523	Vitamin K1	PHYTONADIONE	A-S Medication Solutions	ANDA	Current
50090-4523	Vitamin K1	PHYTONADIONE	A-S Medication Solutions	ANDA	Current
50090-4523	Vitamin K1	PHYTONADIONE	A-S Medication Solutions	ANDA	Current
50090-4523	Vitamin K1	PHYTONADIONE	A-S Medication Solutions	ANDA	Current
51662-1537	VITAMIN K1 PHYTONADIONE	VITAMIN K1, PHYTONADIONE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
55154-2388	Vitamin K1	PHYTONADIONE	Cardinal Health	ANDA	Current