Terbutaline Sulfate
Terbutaline Sulfate Tablets, USP Rx Only
Approved
Approval ID
859267c6-3d14-4123-9b9d-4fc248f09726
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2023
Manufacturers
FDA
Chartwell RX, LLC.
DUNS: 079394054
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 Code62135-524
Application NumberANDA077152
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbutaline Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2023
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TERBUTALINE SULFATEActive
Quantity: 2.5 mg in 1 1
Code: 576PU70Y8E
Classification: ACTIB
Terbutaline Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-525
Application NumberANDA077152
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbutaline Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2023
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TERBUTALINE SULFATEActive
Quantity: 5 mg in 1 1
Code: 576PU70Y8E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT