NDC 0378-3225

candesartan cilexetil

Candesartan Cilexetil

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

Product ID0378-3225_1ef1afb2-a661-49d5-ab80-4b41e2369c63
NDC0378-3225
Product TypeHuman Prescription Drug
Proprietary Namecandesartan cilexetil
Generic NameCandesartan Cilexetil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-01-06
Marketing CategoryANDA / ANDA
Application NumberANDA078702
Labeler NameMylan Pharmaceuticals 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 Through2022-12-31

Packaging

NDC 0378-3225-77

90 TABLET in 1 BOTTLE, PLASTIC (0378-3225-77)
Marketing Start Date2020-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3225-93 [00378322593]

candesartan cilexetil TABLET
Marketing CategoryANDA
Application NumberANDA078702
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-06

NDC 0378-3225-77 [00378322577]

candesartan cilexetil TABLET
Marketing CategoryANDA
Application NumberANDA078702
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-06

Drug Details

Active Ingredients

IngredientStrength
CANDESARTAN CILEXETIL8 mg/1

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.