Nalbuphine Hydrochloride

Product NDC: 52584-463
Requested package NDC: 52584-463-01
11-digit product format: 525840463
Labeler code: 52584
Product ID: 52584-463_ef7d41c3-d6a5-40aa-b920-9e2e25d4a8f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nalbuphine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: General Injectables & Vaccines, Inc
Application: ANDA070914
Marketing category: ANDA
Marketing start: 2010-03-01
Marketing end: 2023-09-01
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: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52584-463	52584-463-01	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A070914-001	NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE	10MG/ML (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
A070914-001	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.

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
2026-08-01 22:54:32	2026-06	A070914-001	NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	RS	1989-02-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A070914-001	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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.	a99fe500-f52b-483c-807c-178f1a78a02b	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070914 application number: ANDA070914
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Hospira, Inc.	6025e8d4-5083-4c3a-58a0-050e7b0b6150	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070914 application number: ANDA070914
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Henry Schein, Inc.	596826ff-e471-4d4f-9a73-2a34e2af2dd6	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070914 application number: ANDA070914

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Nalbuphine Hydrochloride	ACTIVE INGREDIENT	ZU4275277R	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2
Nalbuphine	ACTIVE MOIETY	L2T84IQI2K	NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-463-01	52584046301	1 AMPULE in 1 BAG (52584-463-01) > 1 mL in 1 AMPULE	1 ampule	2010-03-01	2023-09-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nalbuphine Hydrochloride 10 mg Injection, USP 1 mL Single Dose Ampule	General Injectables & Vaccines, Inc	2022-12-28	HUMAN PRESCRIPTION DRUG LABEL	8