Terbutaline Sulfate
Terbutaline Sulfate Tablets, USP
Approved
Approval ID
94742710-e87e-4e1c-85ee-0a2e7a77f0de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2020
Manufacturers
FDA
Marlex Pharmaceuticals Inc
DUNS: 782540215
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 Code10135-579
Application NumberANDA077152
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbutaline Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2020
FDA Product Classification
INGREDIENTS (6)
TERBUTALINE SULFATEActive
Quantity: 2.5 mg in 1 1
Code: 576PU70Y8E
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Terbutaline Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-580
Application NumberANDA077152
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbutaline Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2020
FDA Product Classification
INGREDIENTS (6)
TERBUTALINE SULFATEActive
Quantity: 5 mg in 1 1
Code: 576PU70Y8E
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT