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FDA Approval

Terbutaline Sulfate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Rebel Distributors Corp
DUNS: 118802834
Effective Date
December 27, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Terbutaline(5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Rebel Distributors Corp

Rebel Distributors Corp

118802834

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Terbutaline Sulfate

Product Details

NDC Product Code
21695-121
Application Number
ANDA077152
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 21, 2008
povidoneInactive
Code: FZ989GH94EClass: IACT
TerbutalineActive
Code: 576PU70Y8EClass: ACTIBQuantity: 5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Terbutaline Sulfate

Product Details

NDC Product Code
21695-122
Application Number
ANDA077152
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 21, 2008
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TerbutalineActive
Code: 576PU70Y8EClass: ACTIBQuantity: 2.5 mg in 1 1
magnesium stearateInactive
Code: 70097M6I30Class: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMKClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
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