Nalbuphine Hydrochloride

Product NDC: 0404-9766
Requested package NDC: 0404-9766-10
11-digit product format: 004049766
Labeler code: 0404
Product ID: 0404-9766_2d21ad96-ce58-4576-8460-bcc3265e668d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nalbuphine hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Henry Schein, Inc.
Application: ANDA216049
Marketing category: ANDA
Marketing start: 2025-12-10
Substance: NALBUPHINE HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216049-001	NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2024-09-19
A216049-002	NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2024-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216049-001	AP
A216049-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216049-001	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2024-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216049-002	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2024-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216049-001	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2024-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216049-002	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2024-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216049-001	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2024-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216049-002	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2024-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216049-001	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2024-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216049-002	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2024-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216049-001	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2024-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216049-002	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2024-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216049-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2024-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216049-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2024-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216049-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2024-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216049-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2024-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216049-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2024-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216049-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2024-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216049-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2024-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216049-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2024-09-19	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216049-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2024-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216049-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2024-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216049-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2024-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216049-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2024-09-19	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216049-001	NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2024-09-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216049-002	NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2024-09-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216049-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216049-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216049-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216049-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216049-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216049-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216049-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216049-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216049-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216049-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216049-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216049-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216049-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216049-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216049-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216049-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216049-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216049-002	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216049-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216049-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216049-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216049-002	AP	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216049-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216049-002	AP	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216049-001	CGT	2025-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216049-002	CGT	2025-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216049-001	CGT	2025-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216049-002	CGT	2025-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216049-001	CGT	2025-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216049-002	CGT	2025-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216049-001	CGT	2025-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216049-002	CGT	2025-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216049-001	CGT	2025-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216049-002	CGT	2025-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216049-001	CGT	2025-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216049-002	CGT	2025-03-30	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216049-001	CGT	2025-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216049-002	CGT	2025-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216049-001	CGT	2025-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216049-002	CGT	2025-03-30	`d06236e962d9…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NALBUPHINE HYDROCHLORIDE	20 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
904440	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
dd621bfa-ce48-4c27-b247-a6d885f70b72	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9766-10	Nalbuphine Hydrochloride	10 mL in 1 VIAL, MULTI-DOSE	INJECTION	10		2
0404-9766-10	Nalbuphine Hydrochloride	1 in 1 BAG	INJECTION	1		2

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	Henry Schein, Inc.	dd621bfa-ce48-4c27-b247-a6d885f70b72	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216049 application number: ANDA216049 ndc (package): 0404-9766-10 ndc (product): 0404-9766 ndc11 (package): 00404976610
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Henry Schein, Inc.	4ef2c0dc-3ab4-4bb1-aff0-523e3c23ad2d	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216049 application number: ANDA216049
Nalbuphine hydrochloride	NALBUPHINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	292b0d0e-f222-d384-e063-6394a90acd44	2024-12-13	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 216049 application number: ANDA216049
Nalbuphine hydrochloride	NALBUPHINE HYDROCHLORIDE	Somerset Therapeutics, LLC	d82dafac-cce7-445a-8127-2a10b6d947ca	2024-09-26	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 216049 application number: ANDA216049

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
904440	nalbuphine HCl 20 MG/ML Injectable Solution	PSN	dd621bfa-ce48-4c27-b247-a6d885f70b72	2
904440	nalbuphine hydrochloride 20 MG/ML Injectable Solution	SCD	dd621bfa-ce48-4c27-b247-a6d885f70b72	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0404-9766-10	00404976610	1 VIAL, MULTI-DOSE in 1 BAG (0404-9766-10) / 10 mL in 1 VIAL, MULTI-DOSE	2025-12-10	No	No	Current