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Active ingredient

Terbutaline

17 finished FDA listings contain Terbutaline as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
TERBUTALINE SULFATE
Dosage forms
Injection, Injection, Solution, Tablet
Routes
Oral, Subcutaneous
Manufacturers / labelers
10
Strengths listed
1 mg/ml · 2.5 mg/1 · 5 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 10368

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
NDA 017849ANI PHARMS1976-05-172
ANDA 075877IMPAX LABS2001-06-262
ANDA 076887FRESENIUS KABI USA2004-05-262
ANDA 077152LANNETT CO INC2005-03-254
ANDA 078630HIKMA FARMACEUTICA2009-05-203
ANDA 211832TWI PHARMS2020-06-194

Official labeling on DailyMed

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