Atenolol
Atenolol Tablets, USP Rx only
Approved
Approval ID
331128cc-f56e-4329-e063-6394a90a5ead
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2025
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 Code68071-3830
Application NumberANDA078512
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (7)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ATENOLOLActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/18/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 2/21/2024
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 2/21/2024
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 2/21/2024
WARNINGS SECTION
LOINC: 34071-1Updated: 2/21/2024
DESCRIPTION SECTION
LOINC: 34089-3Updated: 2/21/2024
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 2/21/2024
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/18/2025
PRECAUTIONS SECTION
LOINC: 42232-9Updated: 2/21/2024
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 2/21/2024
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 2/21/2024