NDC 68382-514

Telmisartan and Hydrochlorothiazide

Telmisartan And Hydrochlorothiazide

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

Product ID68382-514_02f8ec8a-3647-4865-99ad-5562b9ca3940
NDC68382-514
Product TypeHuman Prescription Drug
Proprietary NameTelmisartan and Hydrochlorothiazide
Generic NameTelmisartan And Hydrochlorothiazide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-10-12
Marketing CategoryANDA / ANDA
Application NumberANDA204221
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameTELMISARTAN; HYDROCHLOROTHIAZIDE
Active Ingredient Strength80 mg/1; mg/1
Pharm ClassesIncreased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68382-514-06

30 TABLET in 1 BOTTLE (68382-514-06)
Marketing Start Date2017-10-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-514-16 [68382051416]

Telmisartan and Hydrochlorothiazide TABLET
Marketing CategoryANDA
Application NumberANDA204221
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-12

NDC 68382-514-30 [68382051430]

Telmisartan and Hydrochlorothiazide TABLET
Marketing CategoryANDA
Application NumberANDA204221
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-12

NDC 68382-514-06 [68382051406]

Telmisartan and Hydrochlorothiazide TABLET
Marketing CategoryANDA
Application NumberANDA204221
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-12

NDC 68382-514-84 [68382051484]

Telmisartan and Hydrochlorothiazide TABLET
Marketing CategoryANDA
Application NumberANDA204221
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-12

Drug Details

Active Ingredients

IngredientStrength
TELMISARTAN80 mg/1

OpenFDA Data

SPL SET ID:24f3539e-a993-43f4-bb2e-6ecdc9bda86e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 477130
  • 283317
  • 283316
    • UPC Code
  • 0368382513168
  • 0368382515162

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Telmisartan and Hydrochlorothiazide" or generic name "Telmisartan And Hydrochlorothiazide"

    NDCBrand NameGeneric Name
    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
    68180-194Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    68180-193Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    68180-195Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    68382-514Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    68382-515Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    68382-513Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    68462-840Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    68462-841Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    68462-842Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    70771-1125Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    70771-1123Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    70771-1124Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    63629-7546TELMISARTAN and HYDROCHLOROTHIAZIDETELMISARTAN and HYDROCHLOROTHIAZIDE
    63629-7854Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    65862-976Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    65862-977Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    65862-978Telmisartan and HydrochlorothiazideTelmisartan and Hydrochlorothiazide
    0597-0042Micardis HCTtelmisartan and hydrochlorothiazide
    0597-0043Micardis HCTtelmisartan and hydrochlorothiazide
    0597-0044Micardis HCTtelmisartan and hydrochlorothiazide
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