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Atenolol

Atenolol Tablets USP 25 mg, 50 mg and 100 mg

Approved
Approval ID

73671d55-3e10-cb1d-e053-2991aa0ac038

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 15, 2021

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

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 Code68071-4527
Application NumberANDA077443
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2021
FDA Product Classification

INGREDIENTS (8)

HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ATENOLOLActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB

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Atenolol - FDA Drug Approval Details