NDC 68382-191

Candesartan cilexetil

Candesartan Cilexetil

Candesartan cilexetil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Candesartan Cilexetil.

Product ID68382-191_792640e3-48e8-47ee-9947-e433dde860b7
NDC68382-191
Product TypeHuman Prescription Drug
Proprietary NameCandesartan cilexetil
Generic NameCandesartan Cilexetil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-02-22
Marketing CategoryANDA / ANDA
Application NumberANDA091390
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameCANDESARTAN CILEXETIL
Active Ingredient Strength8 mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68382-191-05

500 TABLET in 1 BOTTLE (68382-191-05)
Marketing Start Date2018-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-191-16 [68382019116]

Candesartan cilexetil TABLET
Marketing CategoryANDA
Application NumberANDA091390
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-22

NDC 68382-191-05 [68382019105]

Candesartan cilexetil TABLET
Marketing CategoryANDA
Application NumberANDA091390
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-22

NDC 68382-191-06 [68382019106]

Candesartan cilexetil TABLET
Marketing CategoryANDA
Application NumberANDA091390
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-22

Drug Details

Active Ingredients

IngredientStrength
CANDESARTAN CILEXETIL8 mg/1

OpenFDA Data

SPL SET ID:9c221170-1888-4878-8dbb-7475494657e6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 577776
  • 153823
  • 153822
  • 639537

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0378-3224candesartan cilexetilcandesartan cilexetil
    0378-3225candesartan cilexetilcandesartan cilexetil
    0378-3231candesartan cilexetilcandesartan cilexetil
    0378-3232candesartan cilexetilcandesartan cilexetil
    0781-5936Candesartan cilexetilCandesartan cilexetil
    0781-5937Candesartan cilexetilCandesartan cilexetil
    0781-5938Candesartan cilexetilCandesartan cilexetil
    0781-5939Candesartan cilexetilCandesartan cilexetil
    46708-060CANDESARTAN CILEXETILCANDESARTAN CILEXETIL
    46708-341CANDESARTAN CILEXETILCANDESARTAN CILEXETIL
    46708-342CANDESARTAN CILEXETILCANDESARTAN CILEXETIL
    46708-343CANDESARTAN CILEXETILCANDESARTAN CILEXETIL
    49884-658Candesartan cilexetilCandesartan cilexetil
    49884-659Candesartan cilexetilCandesartan cilexetil
    49884-660Candesartan cilexetilCandesartan cilexetil
    49884-661Candesartan cilexetilCandesartan cilexetil
    60687-119Candesartan cilexetilCandesartan cilexetil
    60687-130Candesartan cilexetilCandesartan cilexetil
    60687-241Candesartan cilexetilCandesartan cilexetil
    68151-3838Candesartan cilexetilCandesartan cilexetil
    68382-191Candesartan cilexetilCandesartan cilexetil
    68382-193Candesartan cilexetilCandesartan cilexetil
    68382-192Candesartan cilexetilCandesartan cilexetil
    68382-190Candesartan cilexetilCandesartan cilexetil
    70771-1206Candesartan cilexetilCandesartan cilexetil
    70771-1207Candesartan cilexetilCandesartan cilexetil
    70771-1204Candesartan cilexetilCandesartan cilexetil
    70771-1205Candesartan cilexetilCandesartan cilexetil
    62332-342CANDESARTAN CILEXETILCANDESARTAN CILEXETIL
    62332-341CANDESARTAN CILEXETILCANDESARTAN CILEXETIL
    62332-343CANDESARTAN CILEXETILCANDESARTAN CILEXETIL
    62332-060CANDESARTAN CILEXETILCANDESARTAN CILEXETIL
    0186-0004ATACANDCandesartan cilexetil
    0186-0008ATACANDCandesartan cilexetil
    0186-0016ATACANDCandesartan cilexetil
    0186-0032ATACANDCandesartan cilexetil
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