NDC 0378-0231

Atenolol

Atenolol

Atenolol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Atenolol.

Product ID0378-0231_25b4b9e7-65f3-42ef-9e59-e1eeaf39b5fe
NDC0378-0231
Product TypeHuman Prescription Drug
Proprietary NameAtenolol
Generic NameAtenolol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1992-01-24
Marketing CategoryANDA / ANDA
Application NumberANDA073457
Labeler NameMylan Pharmaceuticals Inc.
Substance NameATENOLOL
Active Ingredient Strength50 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-0231-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0231-01)
Marketing Start Date1992-01-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0231-10 [00378023110]

Atenolol TABLET
Marketing CategoryANDA
Application NumberANDA073457
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1992-01-24

NDC 0378-0231-77 [00378023177]

Atenolol TABLET
Marketing CategoryANDA
Application NumberANDA073457
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-01

NDC 0378-0231-01 [00378023101]

Atenolol TABLET
Marketing CategoryANDA
Application NumberANDA073457
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1992-01-24

Drug Details

Active Ingredients

IngredientStrength
ATENOLOL50 mg/1

OpenFDA Data

SPL SET ID:a7048c81-6769-436b-8397-fbaa7489fcdf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197379
  • 197380
  • 197381
    • UPC Code
  • 0646380218712

    • Pharmacological Class

    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]

    NDC Crossover Matching brand name "Atenolol" or generic name "Atenolol"

    NDCBrand NameGeneric Name
    0093-0752AtenololAtenolol
    0093-0753AtenololAtenolol
    0093-0787AtenololAtenolol
    0378-0218Atenololatenolol
    0378-0231Atenololatenolol
    0378-0757Atenololatenolol
    0615-3532Atenololatenolol
    0615-3533Atenololatenolol
    0615-3544AtenololAtenolol
    0615-8026AtenololAtenolol
    0615-8027AtenololAtenolol
    0615-8372AtenololAtenolol
    0615-8373AtenololAtenolol
    0781-1078AtenololAtenolol
    0781-1506AtenololAtenolol
    0781-1507AtenololAtenolol
    0781-5220AtenololAtenolol
    0781-5225AtenololAtenolol
    0781-5229AtenololAtenolol
    0904-5392AtenololAtenolol
    0904-7187AtenololAtenolol
    68071-1771AtenololAtenolol
    68071-1772AtenololAtenolol
    68071-3190AtenololAtenolol
    68071-3320AtenololAtenolol
    68071-4274AtenololAtenolol
    68071-3224AtenololAtenolol
    68071-3335AtenololAtenolol
    68071-4527AtenololAtenolol
    68071-4526AtenololAtenolol
    68071-4538AtenololAtenolol
    68071-4751AtenololAtenolol
    68071-4766AtenololAtenolol
    68071-4553AtenololAtenolol
    68151-2889AtenololAtenolol
    68151-2471AtenololAtenolol
    68382-024AtenololAtenolol
    68382-022AtenololAtenolol
    68382-023AtenololAtenolol
    68645-493AtenololAtenolol
    68788-6450AtenololAtenolol
    68788-6969AtenololAtenolol
    68788-7071AtenololAtenolol
    68788-9048AtenololAtenolol
    68788-6458AtenololAtenolol
    68788-7368AtenololAtenolol
    68788-9049AtenololAtenolol
    68788-9761AtenololAtenolol
    68788-9047AtenololAtenolol
    68788-9236AtenololAtenolol
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.