FDA.reportPublic FDA data

Nalbuphine Hydrochloride

Product NDC
52584-463
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52584-463DDiscontinued by firm2026-07-31
excluded packagepackage52584-46352584-463-01DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070914-001NALBUPHINE HYDROCHLORIDENALBUPHINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRS1989-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070914-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A070914-001NALBUPHINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRS1989-02-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A070914-001AP1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.a99fe500-f52b-483c-807c-178f1a78a02b2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070914
application number: ANDA070914
Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.6025e8d4-5083-4c3a-58a0-050e7b0b61502025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070914
application number: ANDA070914
Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHenry Schein, Inc.596826ff-e471-4d4f-9a73-2a34e2af2dd62025-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070914
application number: ANDA070914

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nalbuphine HydrochlorideACTIVE INGREDIENTZU4275277RNALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]2
NalbuphineACTIVE MOIETYL2T84IQI2KNALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-463-01525840463011 AMPULE in 1 BAG (52584-463-01) > 1 mL in 1 AMPULE1 ampule2010-03-010000-00-00NoNoCurrent