Nalbuphine Hydrochloride

Product NDC: 84549-464
Requested package NDC: 84549-464-01
11-digit product format: 845490464
Labeler code: 84549
Product ID: 84549-464_463cff7e-0486-7c6d-e063-6294a90ae0e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NALBUPHINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: ProPharma Distribution
Application: ANDA070915
Marketing category: ANDA
Marketing start: 2005-07-19
Substance: NALBUPHINE HYDROCHLORIDE
Active strength: 10 mg/mL
Pharmacologic classes: Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: 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
A070915-001	NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/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
A070915-001	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	A070915-001	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	1989-02-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070915-001	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	1989-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070915-001	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	1989-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070915-001	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	1989-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070915-001	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	1989-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	1989-02-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070915-001	NALBUPHINE HYDROCHLORIDE	10MG/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	A070915-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070915-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070915-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070915-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070915-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070915-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070915-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070915-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070915-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070915-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070915-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070915-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070915-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070915-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070915-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070915-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070915-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070915-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070915-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070915-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070915-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070915-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070915-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070915-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070915-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070915-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070915-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070915-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070915-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070915-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070915-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070915-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070915-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070915-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070915-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070915-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070915-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070915-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070915-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070915-001	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Nalbuphine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NALBUPHINE HYDROCHLORIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ZU4275277R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904415	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
38569b5f-fb37-135e-e063-6294a90a54df	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e665fab2-f6df-99b6-a22d-5d9276f14b80	Product name	3	20250331
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84549-464-01	Nalbuphine Hydrochloride	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10		4

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
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Hospira, Inc.	6025e8d4-5083-4c3a-58a0-050e7b0b6150	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070915 application number: ANDA070915
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	ProPharma Distribution	38569b5f-fb37-135e-e063-6294a90a54df	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070915 application number: ANDA070915 ndc (package): 84549-464-01 ndc (product): 84549-464 ndc11 (package): 84549046401
NALBUPHINE HCI	NALBUPHINE HCI	HF Acquisition Co LLC, DBA HealthFirst	96139914-0708-7b58-e053-2995a90a7308	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070915 application number: ANDA070915
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6bde2184-5643-3ec6-e053-2991aa0a115f	2023-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070915 application number: ANDA070915

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZU4275277R	NALBUPHINE HYDROCHLORIDE	23277-43-2	NALBUPHINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
904415	nalbuphine HCl 10 MG/ML Injectable Solution	PSN	38569b5f-fb37-135e-e063-6294a90a54df	4
904415	nalbuphine hydrochloride 10 MG/ML Injectable Solution	SCD	38569b5f-fb37-135e-e063-6294a90a54df	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84549-464-01	84549046401	10 mL in 1 VIAL, MULTI-DOSE (84549-464-01)	10 ml	2025-08-27	No	No	Current