Application 018024

Type: NDA
Sponsor: PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUBAIN	NALBUPHINE HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	NUBAIN	NALBUPHINE HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	NUBAIN	NALBUPHINE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No
004	NUBAIN	NALBUPHINE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	20MG/2ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No
005	NUBAIN	NALBUPHINE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	200MG/10ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018024-001	NUBAIN	NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, Approved before 1982
N018024-002	NUBAIN	NALBUPHINE HYDROCHLORIDE	20MG/ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1982-05-27
N018024-003	NUBAIN	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, Approved before 1982
N018024-004	NUBAIN	NALBUPHINE HYDROCHLORIDE	20MG/2ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, Approved before 1982
N018024-005	NUBAIN	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1984-03-02

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 2 of 3 · 109 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018024-001	NUBAIN	10MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018024-002	NUBAIN	20MG/ML	INJECTABLE / INJECTION	RLD	1982-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018024-001	NUBAIN	10MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018024-002	NUBAIN	20MG/ML	INJECTABLE / INJECTION	RLD	1982-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018024-001	NUBAIN	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018024-002	NUBAIN	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1982-05-27	`6a51e52b5d6a…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Hospira, Inc.	a99fe500-f52b-483c-807c-178f1a78a02b	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Henry Schein, Inc.	dd621bfa-ce48-4c27-b247-a6d885f70b72	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Henry Schein, Inc.	4ef2c0dc-3ab4-4bb1-aff0-523e3c23ad2d	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Hospira, Inc.	6025e8d4-5083-4c3a-58a0-050e7b0b6150	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	ProPharma Distribution	38569b5f-fb37-135e-e063-6294a90a54df	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Henry Schein, Inc.	596826ff-e471-4d4f-9a73-2a34e2af2dd6	2025-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine hydrochloride	NALBUPHINE HYDROCHLORIDE	Somerset Therapeutics, LLC	a3221c05-5822-4ab8-b589-0e3939b91a68	2025-03-26	Boxed warning, Adverse reactions	Name fallback generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine hydrochloride	NALBUPHINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	292b0d0e-f222-d384-e063-6394a90acd44	2024-12-13	Boxed warning, Adverse reactions	Name fallback generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	28f274a4-62c4-4e54-e063-6394a90a2200	2024-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine hydrochloride	NALBUPHINE HYDROCHLORIDE	Somerset Therapeutics, LLC	d82dafac-cce7-445a-8127-2a10b6d947ca	2024-09-26	Boxed warning, Adverse reactions	Name fallback generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6bde2184-5643-3ec6-e053-2991aa0a115f	2023-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: NALBUPHINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84706	SUPPL	2026-01-07
84555	SUPPL	2025-12-29
77027	SUPPL	2023-12-19
76949	SUPPL	2023-12-18
60298	SUPPL	2019-10-08
60283	SUPPL	2019-10-07
46404	SUPPL	2016-12-21
46213	SUPPL	2016-12-19
20103	SUPPL	2007-08-06
40772	SUPPL	2007-07-18
33394	SUPPL	2005-08-31
13982	SUPPL	2005-08-31
786	SUPPL	2003-05-30