NDC 68382-722

Nateglinide

Nateglinide

Nateglinide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Nateglinide.

Product ID68382-722_716586d5-0843-4613-84a9-ea1c972229ff
NDC68382-722
Product TypeHuman Prescription Drug
Proprietary NameNateglinide
Generic NameNateglinide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-10-27
Marketing CategoryANDA / ANDA
Application NumberANDA205248
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameNATEGLINIDE
Active Ingredient Strength120 mg/1
Pharm ClassesGlinide [EPC],Potassium Channel Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68382-722-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-722-01)
Marketing Start Date2016-10-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-722-05 [68382072205]

Nateglinide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205248
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-27

NDC 68382-722-06 [68382072206]

Nateglinide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205248
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-27

NDC 68382-722-16 [68382072216]

Nateglinide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205248
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-27

NDC 68382-722-77 [68382072277]

Nateglinide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205248
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-27

NDC 68382-722-10 [68382072210]

Nateglinide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205248
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-27

NDC 68382-722-30 [68382072230]

Nateglinide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205248
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-27
Marketing End Date2018-12-20

NDC 68382-722-01 [68382072201]

Nateglinide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205248
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-27

Drug Details

Active Ingredients

IngredientStrength
NATEGLINIDE120 mg/1

OpenFDA Data

SPL SET ID:88698921-cd8f-4d41-96e6-ff671913c5c3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311919
  • 314142
  • Pharmacological Class

    • Glinide [EPC]
    • Potassium Channel Antagonists [MoA]

    Medicade Reported Pricing

    68382072216 NATEGLINIDE 120 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0591-3354NateglinideNateglinide
    0591-3355NateglinideNateglinide
    0615-7585NateglinideNateglinide
    0615-7586NateglinideNateglinide
    16571-758NATEGLINIDENATEGLINIDE
    16571-759NATEGLINIDENATEGLINIDE
    42291-636NateglinideNateglinide
    42291-637NateglinideNateglinide
    49884-984NateglinideNateglinide
    49884-985NateglinideNateglinide
    51407-656Nateglinidenateglinide
    51407-657Nateglinidenateglinide
    52536-063NateglinideNateglinide
    52536-067NateglinideNateglinide
    55111-328NateglinideNateglinide
    55111-329NateglinideNateglinide
    60429-434NateglinideNateglinide
    60429-435NateglinideNateglinide
    60687-673Nateglinidenateglinide
    60687-684Nateglinidenateglinide
    64380-167Nateglinidenateglinide
    64380-168Nateglinidenateglinide
    68084-458NateglinideNateglinide
    68084-459NateglinideNateglinide
    68382-721NateglinideNateglinide
    68382-722NateglinideNateglinide
    70771-1016NateglinideNateglinide
    70771-1015NateglinideNateglinide
    71209-030NateglinideNateglinide
    71209-031NateglinideNateglinide
    75834-205NATEGLINIDENATEGLINIDE
    75834-206NATEGLINIDENATEGLINIDE
    0078-0351Starlixnateglinide
    0078-0352Starlixnateglinide

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