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Active ingredient

Nalbuphine

18 finished FDA listings contain Nalbuphine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
NALBUPHINE HYDROCHLORIDE
Dosage forms
Injection, Injection, Solution
Routes
Intramuscular, Intravenous, Subconjunctival, Subcutaneous
Manufacturers / labelers
6
Strengths listed
10 mg/ml · 20 mg/ml

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7238

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 070915HOSPIRA1989-02-034
ANDA 070914HOSPIRA1989-02-033
ANDA 070918HOSPIRA1989-02-033
ANDA 070916HOSPIRA1989-02-031
ANDA 216049SOMERSET THERAPS LLC2024-09-195
ANDA 216050SOMERSET THERAPS LLC2024-09-192

Official labeling on DailyMed

Showing the 12 most recent of 13 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.