TERBUTALINE SULFATE
Terbutaline Sulfate Tablets, USP (2.5 mg and 5 mg)
Approved
Approval ID
382dcebb-6e41-4335-818d-b5822e3fb884
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2020
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TERBUTALINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-2622
Application NumberANDA075877
Product Classification
M
Marketing Category
C73584
G
Generic Name
TERBUTALINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2020
FDA Product Classification
INGREDIENTS (7)
TERBUTALINE SULFATEActive
Quantity: 5 mg in 1 1
Code: 576PU70Y8E
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TERBUTALINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-2611
Application NumberANDA075877
Product Classification
M
Marketing Category
C73584
G
Generic Name
TERBUTALINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2020
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TERBUTALINE SULFATEActive
Quantity: 2.5 mg in 1 1
Code: 576PU70Y8E
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT