NDC 0597-0042

Micardis HCT

Telmisartan And Hydrochlorothiazide

Micardis HCT is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Telmisartan; Hydrochlorothiazide.

Product ID0597-0042_64edc938-3550-459f-bd41-22647284c10b
NDC0597-0042
Product TypeHuman Prescription Drug
Proprietary NameMicardis HCT
Generic NameTelmisartan And Hydrochlorothiazide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2000-12-01
Marketing CategoryNDA / NDA
Application NumberNDA021162
Labeler NameBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameTELMISARTAN; HYDROCHLOROTHIAZIDE
Active Ingredient Strength80 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 0597-0042-37

3 BLISTER PACK in 1 CARTON (0597-0042-37) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2000-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0042-37 [00597004237]

Micardis HCT TABLET
Marketing CategoryNDA
Application NumberNDA021162
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-12-01

NDC 0597-0042-70 [00597004270]

Micardis HCT TABLET
Marketing CategoryNDA
Application NumberNDA021162
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-10-23
Marketing End Date2012-11-06

Drug Details

Active Ingredients

IngredientStrength
TELMISARTAN80 mg/1

OpenFDA Data

SPL SET ID:b078dae2-664d-4144-847a-3b9d9b557402
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 749841
  • 477130
  • 749837
  • 749833
  • 283317
  • 283316
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Micardis HCT" or generic name "Telmisartan And Hydrochlorothiazide"

    NDCBrand NameGeneric Name
    0597-0042Micardis HCTtelmisartan and hydrochlorothiazide
    0597-0043Micardis HCTtelmisartan and hydrochlorothiazide
    0597-0044Micardis HCTtelmisartan and hydrochlorothiazide
    0054-0545telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazide
    0054-0546telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazide
    0054-0547telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazide
    33342-128TELMISARTAN and HYDROCHLOROTHIAZIDETELMISARTAN and HYDROCHLOROTHIAZIDE
    33342-129TELMISARTAN and HYDROCHLOROTHIAZIDETELMISARTAN and HYDROCHLOROTHIAZIDE
    33342-130TELMISARTAN and HYDROCHLOROTHIAZIDETELMISARTAN and HYDROCHLOROTHIAZIDE
    43547-441TELMISARTAN AND HYDROCHLOROTHIAZIDEtelmisartan and hydrochlorothiazide
    43547-442TELMISARTAN AND HYDROCHLOROTHIAZIDEtelmisartan and hydrochlorothiazide
    43547-443TELMISARTAN AND HYDROCHLOROTHIAZIDEtelmisartan and hydrochlorothiazide
    46708-209Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    46708-210Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    46708-211Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    62332-209Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    62332-210Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    62332-211Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide

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