MedPath

Pindolol

PINDOLOL TABLETS USP

Approved
Approval ID

e1049edf-376e-317b-e053-2995a90a2aac

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 6, 2023

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.

Pindolol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10135-744
Application NumberANDA073609
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pindolol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2023
FDA Product Classification

INGREDIENTS (5)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
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 Code10135-743
Application NumberANDA073609
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pindolol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2023
FDA Product Classification

INGREDIENTS (5)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PINDOLOLActive
Quantity: 5 mg in 1 1
Code: BJ4HF6IU1D
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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