NDC 71205-301

Valsartan

Valsartan

Valsartan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Valsartan.

Product ID71205-301_7e90cfaa-2e1c-4876-807c-9ce29d63e338
NDC71205-301
Product TypeHuman Prescription Drug
Proprietary NameValsartan
Generic NameValsartan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-09-19
Marketing CategoryANDA / ANDA
Application NumberANDA202696
Labeler NameProficient Rx LP
Substance NameVALSARTAN
Active Ingredient Strength320 mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 71205-301-30

30 TABLET, FILM COATED in 1 BOTTLE (71205-301-30)
Marketing Start Date2019-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71205-301-90 [71205030190]

Valsartan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202696
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-01

NDC 71205-301-60 [71205030160]

Valsartan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202696
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-01

NDC 71205-301-30 [71205030130]

Valsartan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202696
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
VALSARTAN320 mg/1

OpenFDA Data

SPL SET ID:fadb25bb-acd9-4aaf-971c-82259b739e5b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349200
  • 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 "Valsartan" or generic name "Valsartan"

    NDCBrand NameGeneric Name
    0378-5807Valsartanvalsartan
    0378-5813Valsartanvalsartan
    0378-5814Valsartanvalsartan
    0378-5815Valsartanvalsartan
    0591-2167Valsartanvalsartan
    0591-2168Valsartanvalsartan
    0591-2169Valsartanvalsartan
    0591-2170Valsartanvalsartan
    0781-5607Valsartanvalsartan
    0781-5608Valsartanvalsartan
    0781-5618Valsartanvalsartan
    0781-5619Valsartanvalsartan
    0904-6594Valsartanvalsartan
    0904-6595Valsartanvalsartan
    10135-768ValsartanValsartan
    10135-769ValsartanValsartan
    10135-770ValsartanValsartan
    10135-771ValsartanValsartan
    67877-416ValsartanValsartan
    67877-418ValsartanValsartan
    67877-417ValsartanValsartan
    67877-415ValsartanValsartan
    68180-278ValsartanValsartan
    68180-277ValsartanValsartan
    68180-279ValsartanValsartan
    68180-276ValsartanValsartan
    68788-6814ValsartanValsartan
    68788-6882ValsartanValsartan
    70518-0069ValsartanValsartan
    70518-1279ValsartanValsartan
    71335-0097ValsartanValsartan
    71335-0567ValsartanValsartan
    71335-0600ValsartanValsartan
    71335-0475ValsartanValsartan
    71335-0488ValsartanValsartan
    76483-026ValsartanValsartan
    76483-024ValsartanValsartan
    76483-023ValsartanValsartan
    76483-025ValsartanValsartan
    13668-067valsartanvalsartan
    13668-068valsartanvalsartan
    13668-069valsartanvalsartan
    13668-070valsartanvalsartan
    29300-235ValsartanValsartan
    29300-232ValsartanValsartan
    31722-747ValsartanValsartan
    29300-233ValsartanValsartan
    29300-234ValsartanValsartan
    31722-748ValsartanValsartan
    33342-062ValsartanValsartan

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.