NDC 42291-513

Pioglitazone and Metformin Hydrochloride

Pioglitazone And Metformin Hydrochloride

Pioglitazone and Metformin Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Avkare, Inc.. The primary component is Pioglitazone Hydrochloride; Metformin Hydrochloride.

Product ID42291-513_63a0189b-1147-838e-e053-2991aa0a8dc2
NDC42291-513
Product TypeHuman Prescription Drug
Proprietary NamePioglitazone and Metformin Hydrochloride
Generic NamePioglitazone And Metformin Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-03-06
Marketing CategoryANDA / ANDA
Application NumberANDA091155
Labeler NameAvKARE, Inc.
Substance NamePIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE
Active Ingredient Strength15 mg/1; mg/1
Pharm ClassesPeroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Biguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42291-513-60

60 TABLET, FILM COATED in 1 BOTTLE (42291-513-60)
Marketing Start Date2015-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-513-60 [42291051360]

Pioglitazone and Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091155
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-06
Marketing End Date2019-03-31

Drug Details

Active Ingredients

IngredientStrength
PIOGLITAZONE HYDROCHLORIDE15 mg/1

OpenFDA Data

SPL SET ID:dc314f38-26dc-0b66-d533-065d90fe7375
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861783
  • 861822
    • UPC Code
  • 0342291512603
  • 0342291513600

    • Pharmacological Class

    • Peroxisome Proliferator-activated Receptor Activity [MoA]
    • PPAR alpha [CS]
    • PPAR gamma [CS]
    • Thiazolidinedione [EPC]
    • Thiazolidinediones [CS]
    • Peroxisome Proliferator Receptor alpha Agonist [EPC]
    • Peroxisome Proliferator Receptor gamma Agonist [EPC]
    • Biguanide [EPC]
    • Biguanides [CS]

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

    NDCBrand NameGeneric Name
    0093-7677Pioglitazone and Metformin HydrochloridePioglitazone and Metformin Hydrochloride
    0093-7678Pioglitazone and Metformin HydrochloridePioglitazone and Metformin Hydrochloride
    42291-512Pioglitazone and Metformin HydrochloridePioglitazone and Metformin Hydrochloride
    42291-513Pioglitazone and Metformin HydrochloridePioglitazone and Metformin Hydrochloride
    64764-155Actoplus Metpioglitazone and metformin hydrochloride
    64764-158Actoplus Metpioglitazone and metformin hydrochloride
    64764-310Actoplus Metpioglitazone and metformin hydrochloride
    64764-510Actoplus Metpioglitazone and metformin hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.