MedPath

Atenolol

ATENOLOL TABLETS USP078707520753Rx only

Approved
Approval ID

c4e3ebde-1b80-4177-a6d8-fb0cab16613d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 1, 2017

Manufacturers
FDA

Aidarex Pharmaceuticals LLC

DUNS: 801503249

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Atenolol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53217-201
Application NumberANDA074056
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2017
FDA Product Classification

INGREDIENTS (5)

ATENOLOLActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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