Pindolol
Approved
Approval ID
0648878e-ba6e-4901-948e-f6dcff9fe082
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2018
Manufacturers
FDA
Nostrum Laboratories, Inc.
DUNS: 791142354
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pindolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29033-029
Application NumberANDA205415
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pindolol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2018
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PINDOLOLActive
Quantity: 10 mg in 1 1
Code: BJ4HF6IU1D
Classification: ACTIB
Pindolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29033-028
Application NumberANDA205415
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pindolol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2018
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PINDOLOLActive
Quantity: 5 mg in 1 1
Code: BJ4HF6IU1D
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT