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Pindolol

PINDOLOL TABLETS, USP

Approved
Approval ID

b5a5a1e9-ee9b-41b1-b2d5-5f5834b816a7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 13, 2022

Manufacturers
FDA

Zydus Lifesciences Limited

DUNS: 918596198

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 Code70771-1134
Application NumberANDA209866
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pindolol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification

INGREDIENTS (7)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PINDOLOLActive
Quantity: 5 mg in 1 1
Code: BJ4HF6IU1D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

Pindolol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70771-1135
Application NumberANDA209866
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pindolol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification

INGREDIENTS (7)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PINDOLOLActive
Quantity: 10 mg in 1 1
Code: BJ4HF6IU1D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

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Pindolol - FDA Drug Approval Details