NDC 0078-0351

Starlix

Nateglinide

Starlix is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Nateglinide.

Product ID0078-0351_30f5d4e8-235e-437d-8586-76bae702e8b2
NDC0078-0351
Product TypeHuman Prescription Drug
Proprietary NameStarlix
Generic NameNateglinide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2000-12-04
Marketing CategoryNDA / NDA
Application NumberNDA021204
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameNATEGLINIDE
Active Ingredient Strength60 mg/1
Pharm ClassesGlinide [EPC],Potassium Channel Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0078-0351-05

100 TABLET in 1 BOTTLE (0078-0351-05)
Marketing Start Date2000-12-04
Marketing End Date2021-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0351-05 [00078035105]

Starlix TABLET
Marketing CategoryNDA
Application NumberNDA021204
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-12-04
Marketing End Date2021-09-30

Drug Details

Active Ingredients

IngredientStrength
NATEGLINIDE60 mg/1

OpenFDA Data

SPL SET ID:5cbda9bc-3c0d-4d75-a37a-994844680c8c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 284529
  • 284530
  • 311919
  • 314142
  • UPC Code
  • 0300780351058
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0078-0351Starlixnateglinide
    0078-0352Starlixnateglinide
    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

    Trademark Results [Starlix]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    STARLIX
    STARLIX
    74614502 not registered Dead/Abandoned
    SANDOZ AG (SANDOZ LTD., SANDOZ S.A.)
    1994-12-22
    STARLIX
    STARLIX
    74476003 2152672 Live/Registered
    Novartis AG
    1994-01-03

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