Terbutaline Sulfate

Product NDC
0404-9778
11-digit product format
004049778
Labeler code
0404
Product ID
0404-9778_d7e57299-acd7-41cf-9cfb-229cba799be6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
terbutaline sulfate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Henry Schein, Inc.
Application
ANDA078630
Marketing category
ANDA
Marketing start
2025-10-07
Substance
TERBUTALINE SULFATE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
576PU70Y8ETERBUTALINE SULFATE23031-32-5TERBUTALINE SULFATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0404-9778-01004049778011 VIAL in 1 BAG (0404-9778-01) / 1 mL in 1 VIAL1 vial2025-10-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TERBUTALINE SULFATE INJECTIONHenry Schein, Inc.2025-08-28HUMAN PRESCRIPTION DRUG LABEL1