NDC 0378-2922

Telmisartan

Telmisartan

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

Product ID0378-2922_760d68d2-481a-45c4-bd18-491403f160c6
NDC0378-2922
Product TypeHuman Prescription Drug
Proprietary NameTelmisartan
Generic NameTelmisartan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-07-07
Marketing CategoryANDA / ANDA
Application NumberANDA202397
Labeler NameMylan Pharmaceuticals Inc.
Substance NameTELMISARTAN
Active Ingredient Strength80 mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-2922-77

90 TABLET in 1 BOTTLE, PLASTIC (0378-2922-77)
Marketing Start Date2014-07-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-2922-05 [00378292205]

Telmisartan TABLET
Marketing CategoryANDA
Application NumberANDA202397
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-07-07
Marketing End Date2015-02-09

NDC 0378-2922-77 [00378292277]

Telmisartan TABLET
Marketing CategoryANDA
Application NumberANDA202397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-07

NDC 0378-2922-93 [00378292293]

Telmisartan TABLET
Marketing CategoryANDA
Application NumberANDA202397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-07

Drug Details

Active Ingredients

IngredientStrength
TELMISARTAN80 mg/1

OpenFDA Data

SPL SET ID:c3658bc8-1524-43db-930e-66f9ac01b808
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 282755
  • 205304
  • 205305
    • UPC Code
  • 0303782922936
  • 0303782921939
  • 0303782920932

    • Pharmacological Class

    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]
    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]

    NDC Crossover Matching brand name "Telmisartan" or generic name "Telmisartan"

    NDCBrand NameGeneric Name
    0054-0542Telmisartantelmisartan
    0054-0543Telmisartantelmisartan
    0054-0544Telmisartantelmisartan
    0378-2920Telmisartantelmisartan
    0378-2921Telmisartantelmisartan
    0378-2922Telmisartantelmisartan
    0591-3293TelmisartanTelmisartan
    0591-3294TelmisartanTelmisartan
    0781-5372TelmisartanTelmisartan
    0781-5374TelmisartanTelmisartan
    0781-5378TelmisartanTelmisartan
    13668-156TELMISARTANTELMISARTAN
    13668-157TELMISARTANTELMISARTAN
    13668-158TELMISARTANTELMISARTAN
    31722-802TelmisartanTelmisartan
    31722-803TelmisartanTelmisartan
    31722-804TelmisartanTelmisartan
    42291-790TelmisartanTelmisartan
    67877-483telmisartantelmisartan
    67877-482telmisartantelmisartan
    67877-484telmisartantelmisartan
    68382-471telmisartantelmisartan
    68382-473telmisartantelmisartan
    68382-472telmisartantelmisartan
    68462-200TelmisartanTelmisartan
    68462-201TelmisartanTelmisartan
    68462-199TelmisartanTelmisartan
    71209-051TelmisartanTelmisartan
    71209-049TelmisartanTelmisartan
    71209-050TelmisartanTelmisartan
    71335-0875telmisartantelmisartan
    42291-792TelmisartanTelmisartan
    42291-791TelmisartanTelmisartan
    42571-226TELMISARTANTELMISARTAN
    42571-228TELMISARTANTELMISARTAN
    42571-227TELMISARTANTELMISARTAN
    43547-285TelmisartanTelmisartan
    43547-283TELMISARTANTELMISARTAN
    43547-284TelmisartanTelmisartan
    45865-836TelmisartanTelmisartan
    53746-293TelmisartanTelmisartan
    53746-292TelmisartanTelmisartan
    53746-291TelmisartanTelmisartan
    59746-440TelmisartanTelmisartan
    59746-439TelmisartanTelmisartan
    59746-441TelmisartanTelmisartan
    62332-087TelmisartanTelmisartan
    62332-088TelmisartanTelmisartan
    62332-089TelmisartanTelmisartan
    63187-951telmisartantelmisartan
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