NDC 33342-116

Candesartan

Candesartan

Candesartan is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is Candesartan Cilexetil.

Product ID33342-116_27e8cb6d-e88e-44ea-8f6b-8090e6111e20
NDC33342-116
Product TypeHuman Prescription Drug
Proprietary NameCandesartan
Generic NameCandesartan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-12-06
Marketing CategoryANDA / ANDA
Application NumberANDA203813
Labeler NameMacleods Pharmaceuticals Limited
Substance NameCANDESARTAN CILEXETIL
Active Ingredient Strength16 mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 33342-116-07

30 TABLET in 1 CONTAINER (33342-116-07)
Marketing Start Date2016-12-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33342-116-07 [33342011607]

Candesartan TABLET
Marketing CategoryANDA
Application NumberANDA203813
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-06

NDC 33342-116-10 [33342011610]

Candesartan TABLET
Marketing CategoryANDA
Application NumberANDA203813
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-06

NDC 33342-116-51 [33342011651]

Candesartan TABLET
Marketing CategoryANDA
Application NumberANDA203813
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-06

NDC 33342-116-12 [33342011612]

Candesartan TABLET
Marketing CategoryANDA
Application NumberANDA203813
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-06

Drug Details

Active Ingredients

IngredientStrength
CANDESARTAN CILEXETIL16 mg/1

OpenFDA Data

SPL SET ID:8ceb5658-b03c-475d-9ef0-2cd0645191d3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 577776
  • 153823
  • 153822
  • 639537
  • UPC Code
  • 0333342114105
  • 0333342116109
  • 0333342115072
  • 0333342117106
  • 0333342116079
  • 0333342114075
  • 0333342117076
  • Pharmacological Class

    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]
    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]

    Medicade Reported Pricing

    33342011610 CANDESARTAN CILEXETIL 16 MG TB

    Pricing Unit: EA | Drug Type:

    33342011607 CANDESARTAN CILEXETIL 16 MG TB

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0904-7034CandesartanCandesartan
    33342-114CandesartanCandesartan
    33342-115CandesartanCandesartan
    33342-116CandesartanCandesartan
    33342-117CandesartanCandesartan

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