NDC 46708-210

Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg

Telmisartan And Hydrochlorothiazide

Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Telmisartan; Hydrochlorothiazide.

Product ID46708-210_430d204e-87e7-4aed-a02b-3e1f454d8dcb
NDC46708-210
Product TypeHuman Prescription Drug
Proprietary NameTelmisartan and Hydrochlorothiazide 80 mg/12.5 mg
Generic NameTelmisartan And Hydrochlorothiazide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-03-14
Marketing CategoryANDA / ANDA
Application NumberANDA203010
Labeler NameAlembic Pharmaceuticals Limited
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 46708-210-10

100 TABLET in 1 CARTON (46708-210-10)
Marketing Start Date2014-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-210-10 [46708021010]

Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA203010
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-14

NDC 46708-210-91 [46708021091]

Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA203010
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-14

NDC 46708-210-30 [46708021030]

Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA203010
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-14

Drug Details

Active Ingredients

IngredientStrength
TELMISARTAN80 mg/1

OpenFDA Data

SPL SET ID:5b476740-e3f0-4f68-b07c-cd9eb2fa27ca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 477130
  • 283317
  • 283316
    • UPC Code
  • 0346708210304
  • 0346708209308
  • 0346708211301

    • 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 "Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg" 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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