NDC 0378-3003

Candesartan Cilexetil and Hydrochlorothiazide

Candesartan Cilexetil And Hydrochlorothiazide

Candesartan Cilexetil and Hydrochlorothiazide 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; Hydrochlorothiazide.

Product ID0378-3003_0b3219d5-f1f1-4d73-8040-27f39fd679da
NDC0378-3003
Product TypeHuman Prescription Drug
Proprietary NameCandesartan Cilexetil and Hydrochlorothiazide
Generic NameCandesartan Cilexetil And Hydrochlorothiazide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-12-04
Marketing CategoryANDA / ANDA
Application NumberANDA090704
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Active Ingredient Strength32 mg/1; mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-3003-05

500 TABLET in 1 BOTTLE, PLASTIC (0378-3003-05)
Marketing Start Date2012-12-04
Marketing End Date2022-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3003-77 [00378300377]

Candesartan Cilexetil and Hydrochlorothiazide TABLET
Marketing CategoryANDA
Application NumberANDA090704
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-12-04

NDC 0378-3003-05 [00378300305]

Candesartan Cilexetil and Hydrochlorothiazide TABLET
Marketing CategoryANDA
Application NumberANDA090704
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-12-04

Drug Details

Active Ingredients

IngredientStrength
CANDESARTAN CILEXETIL32 mg/1

OpenFDA Data

SPL SET ID:f3c4f7ed-e667-4528-a675-b032c2a4425d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 578330
  • 578325
  • 802749
    • UPC Code
  • 0303783002774
  • 0303783003771
  • 0303783001777

    • Pharmacological Class

    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]
    • Increased Diuresis [PE]
    • Thiazide Diuretic [EPC]
    • Thiazides [CS]
    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]
    • Increased Diuresis [PE]
    • Thiazide Diuretic [EPC]
    • Thiazides [CS]

    NDC Crossover Matching brand name "Candesartan Cilexetil and Hydrochlorothiazide" or generic name "Candesartan Cilexetil And Hydrochlorothiazide"

    NDCBrand NameGeneric Name
    0378-3001Candesartan Cilexetil and Hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazide
    0378-3002Candesartan Cilexetil and Hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazide
    0378-3003Candesartan Cilexetil and Hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazide
    33342-131Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and Hydrochlorothiazide
    33342-132Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and Hydrochlorothiazide
    33342-133Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and Hydrochlorothiazide
    43547-459candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazide
    43547-460candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazide
    43547-461candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazide
    62559-660Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and Hydrochlorothiazide
    62559-661Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and Hydrochlorothiazide
    62559-662Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and Hydrochlorothiazide
    68382-194candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazide
    68382-416candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazide
    68382-195candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazide
    70771-1326candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazide
    70771-1325candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazide
    70771-1327candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazide
    70518-2720Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and Hydrochlorothiazide
    0186-0162ATACAND HCTCandesartan cilexetil and Hydrochlorothiazide
    0186-0322ATACAND HCTCandesartan cilexetil and Hydrochlorothiazide
    62559-650ATACAND HCTCandesartan Cilexetil and Hydrochlorothiazide
    62559-651ATACAND HCTCandesartan Cilexetil and Hydrochlorothiazide
    62559-652ATACAND HCTCandesartan Cilexetil and Hydrochlorothiazide
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