NDC 68180-491

Repaglinide and Metformin Hydrochloride

Repaglinide And Metformin Hydrochloride

Repaglinide and Metformin Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Metformin Hydrochloride; Repaglinide.

Product ID68180-491_acd637a1-d43a-40da-90aa-247fe927e05a
NDC68180-491
Product TypeHuman Prescription Drug
Proprietary NameRepaglinide and Metformin Hydrochloride
Generic NameRepaglinide And Metformin Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-12-10
Marketing CategoryANDA / ANDA
Application NumberANDA200624
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameMETFORMIN HYDROCHLORIDE; REPAGLINIDE
Active Ingredient Strength500 mg/1; mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS],Glinide [EPC],Potassium Channel Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68180-491-01

100 TABLET in 1 BOTTLE (68180-491-01)
Marketing Start Date2015-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68180-491-03 [68180049103]

Repaglinide and Metformin Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA200624
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-10
Marketing End Date2017-10-31

NDC 68180-491-02 [68180049102]

Repaglinide and Metformin Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA200624
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-10
Marketing End Date2017-10-31

NDC 68180-491-01 [68180049101]

Repaglinide and Metformin Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA200624
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-10
Marketing End Date2017-10-31

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:fdd3b379-f8e5-41bc-8b13-a1b810ba01c8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861790
  • 861787
    • UPC Code
  • 0368180490012
  • 0368180491019

    • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]
    • Glinide [EPC]
    • Potassium Channel Antagonists [MoA]

    NDC Crossover Matching brand name "Repaglinide and Metformin Hydrochloride" or generic name "Repaglinide And Metformin Hydrochloride"

    NDCBrand NameGeneric Name
    68180-490Repaglinide and Metformin HydrochlorideRepaglinide and Metformin Hydrochloride
    68180-491Repaglinide and Metformin HydrochlorideRepaglinide and Metformin Hydrochloride
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