Label: ATENOLOL tablet
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NDC Code(s):
65841-022-01,
65841-022-10,
65841-022-16,
65841-022-24, view more65841-022-40, 65841-023-01, 65841-023-02, 65841-023-10, 65841-023-16, 65841-023-24, 65841-023-40, 65841-024-01, 65841-024-10, 65841-024-16, 65841-024-40
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 3, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ATENOLOL
atenolol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-022 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL 25 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color WHITE (WHITE TO OFF- WHITE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code Z;65 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-022-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 2 NDC:65841-022-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 3 NDC:65841-022-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 4 NDC:65841-022-40 5000 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 5 NDC:65841-022-24 10000 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076900 10/08/2005 ATENOLOL
atenolol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-023 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL 50 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color WHITE (WHITE TO OFF- WHITE) Score 2 pieces Shape ROUND (ROUND) Size 8mm Flavor Imprint Code Z;66 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-023-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 2 NDC:65841-023-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 3 NDC:65841-023-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 4 NDC:65841-023-02 2000 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 5 NDC:65841-023-40 5000 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 6 NDC:65841-023-24 10000 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076900 10/08/2005 ATENOLOL
atenolol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-024 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL 100 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color WHITE (WHITE TO OFF- WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code Z;67 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-024-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 2 NDC:65841-024-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 3 NDC:65841-024-40 5000 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 4 NDC:65841-024-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076900 10/08/2005 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-022, 65841-023, 65841-024) , MANUFACTURE(65841-022, 65841-023, 65841-024) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 677605858 ANALYSIS(65841-022, 65841-023, 65841-024) , MANUFACTURE(65841-022, 65841-023, 65841-024)
