Terbutaline Sulfate
Terbutaline Sulfate Tablets USPRx only
Approved
Approval ID
d810a15b-3e10-4f6c-a36e-8ddecbaba9c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2019
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
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 Code62559-721
Application NumberNDA017849
Product Classification
M
Marketing Category
C73605
G
Generic Name
Terbutaline Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 16, 2018
FDA Product Classification
INGREDIENTS (6)
TERBUTALINE SULFATEActive
Quantity: 2.5 mg in 1 1
Code: 576PU70Y8E
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
Terbutaline Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-722
Application NumberNDA017849
Product Classification
M
Marketing Category
C73605
G
Generic Name
Terbutaline Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 16, 2018
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TERBUTALINE SULFATEActive
Quantity: 5 mg in 1 1
Code: 576PU70Y8E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT