NDC 0781-5374

Telmisartan

Telmisartan

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

Product ID0781-5374_1950390f-5a67-46e2-a1a2-354cfd28dac9
NDC0781-5374
Product TypeHuman Prescription Drug
Proprietary NameTelmisartan
Generic NameTelmisartan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-02-06
Marketing CategoryANDA / ANDA
Application NumberANDA203867
Labeler NameSandoz Inc
Substance NameTELMISARTAN
Active Ingredient Strength40 mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0781-5374-06

10 TABLET in 1 BLISTER PACK (0781-5374-06)
Marketing Start Date2015-02-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5374-06 [00781537406]

Telmisartan TABLET
Marketing CategoryANDA
Application NumberANDA203867
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-06

NDC 0781-5374-64 [00781537464]

Telmisartan TABLET
Marketing CategoryANDA
Application NumberANDA203867
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-06

Drug Details

Active Ingredients

IngredientStrength
TELMISARTAN40 mg/1

OpenFDA Data

SPL SET ID:8ba1e485-7c49-43d8-915e-f4180ef8eb23
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 282755
  • 205304
  • 205305
    • UPC Code
  • 0307815378646
  • 0307815374648
  • 0307815372644

    • Pharmacological Class

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.