Application 074626

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	BUTORPHANOL TARTRATE	INJECTABLE;INJECTION	1MG/ML	No	Yes
002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	BUTORPHANOL TARTRATE	INJECTABLE;INJECTION	2MG/ML	No	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23
A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A074626-001	AP
A074626-002	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 3 · 84 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	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074626-001	BUTORPHANOL TARTRATE PRESERVATIVE FREE	1MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074626-002	BUTORPHANOL TARTRATE PRESERVATIVE FREE	2MG/ML	INJECTABLE / INJECTION	AP	RS	1997-01-23	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A074626-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074626-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074626-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074626-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074626-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074626-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074626-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074626-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074626-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074626-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074626-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074626-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074626-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074626-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074626-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074626-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074626-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074626-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074626-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074626-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074626-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074626-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074626-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074626-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074626-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074626-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074626-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074626-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074626-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074626-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074626-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074626-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074626-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074626-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074626-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074626-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074626-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074626-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074626-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074626-002	AP	1	`bb7c543d1eb4…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butorphanol Tartrate	BUTORPHANOL TARTRATE	Hospira, Inc.	9822ca3f-aee2-46e5-8a96-495400e65d10	2026-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074626 application number: ANDA074626 ndc (product): 0409-1623 ndc (product): 0409-1626

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-1623	Butorphanol Tartrate	Butorphanol Tartrate	Hospira, Inc.	ANDA	Current
0409-1623	Butorphanol Tartrate	Butorphanol Tartrate	Hospira, Inc.	ANDA	Current
0409-1623	Butorphanol Tartrate	Butorphanol Tartrate	Hospira, Inc.	ANDA	Current
0409-1623	Butorphanol Tartrate	Butorphanol Tartrate	Hospira, Inc.	ANDA	Current
0409-1623	Butorphanol Tartrate	Butorphanol Tartrate	Hospira, Inc.	ANDA	Current
0409-1626	BUTORPHANOL TARTRATE	butorphanol tartrate	Hospira, Inc.	ANDA	Current
0409-1626	BUTORPHANOL TARTRATE	butorphanol tartrate	Hospira, Inc.	ANDA	Current
0409-1626	Butorphanol Tartrate	Butorphanol Tartrate	Hospira, Inc.	ANDA	Current
0409-1626	Butorphanol Tartrate	Butorphanol Tartrate	Hospira, Inc.	ANDA	Current
0409-1626	BUTORPHANOL TARTRATE	butorphanol tartrate	Hospira, Inc.	ANDA	Current
0409-1626	Butorphanol Tartrate	Butorphanol Tartrate	Hospira, Inc.	ANDA	Current
0409-1626	BUTORPHANOL TARTRATE	butorphanol tartrate	Hospira, Inc.	ANDA	Current
0409-1626	BUTORPHANOL TARTRATE	butorphanol tartrate	Hospira, Inc.	ANDA	Current
0409-1626	Butorphanol Tartrate	Butorphanol Tartrate	Hospira, Inc.	ANDA	Current
0409-1626	Butorphanol Tartrate	Butorphanol Tartrate	Hospira, Inc.	ANDA	Current