Application 070918

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A070918-001	NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	1989-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070918-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A070918-001	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	1989-02-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070918-001	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	1989-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070918-001	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	1989-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070918-001	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	1989-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070918-001	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	1989-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070918-001	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A070918-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070918-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070918-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070918-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070918-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070918-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070918-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070918-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070918-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070918-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070918-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070918-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070918-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070918-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070918-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070918-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070918-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070918-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070918-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070918-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070918-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070918-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070918-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070918-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070918-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070918-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070918-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070918-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070918-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070918-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070918-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070918-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070918-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070918-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070918-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070918-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070918-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070918-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070918-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070918-001	AP	1	`f41ea6bd6efb…`

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
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Hospira, Inc.	6025e8d4-5083-4c3a-58a0-050e7b0b6150	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070918 application number: ANDA070918 ndc (product): 0409-1467
NALBUPHINE HCI	NALBUPHINE HCI	HF Acquisition Co LLC, DBA HealthFirst	96128b54-24d6-88a3-e053-2a95a90a1c9c	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070918 application number: ANDA070918 ndc (product): 51662-1418
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	28f274a4-62c4-4e54-e063-6394a90a2200	2024-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070918 application number: ANDA070918

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9917	Nalbuphine Hydrochloride	nalbuphine hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9917	Nalbuphine Hydrochloride	nalbuphine hydrochloride	Henry Schein, Inc.	ANDA	Current
0409-1467	Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1467	Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1467	Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1467	Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1467	Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
51662-1418	NALBUPHINE HCI	NALBUPHINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1418	NALBUPHINE HCI	NALBUPHINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-083	Nalbuphine Hydrochloride	nalbuphine hydrochloride	General Injectables and Vaccines,Inc.	ANDA	Current