NDC 0781-5635

Pioglitazone hydrochloride and glimepiride

Pioglitazone Hydrochloride And Glimepiride

Pioglitazone hydrochloride and glimepiride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Pioglitazone Hydrochloride; Glimepiride.

Product ID0781-5635_724cb72e-023e-409c-8979-3a380a2fdc0a
NDC0781-5635
Product TypeHuman Prescription Drug
Proprietary NamePioglitazone hydrochloride and glimepiride
Generic NamePioglitazone Hydrochloride And Glimepiride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-01-08
Marketing CategoryANDA / ANDA
Application NumberANDA201049
Labeler NameSandoz Inc
Substance NamePIOGLITAZONE HYDROCHLORIDE; GLIMEPIRIDE
Active Ingredient Strength30 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],Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0781-5635-10

1000 TABLET in 1 BOTTLE (0781-5635-10)
Marketing Start Date2013-01-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5635-31 [00781563531]

Pioglitazone hydrochloride and glimepiride TABLET
Marketing CategoryANDA
Application NumberANDA201049
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-01-08

NDC 0781-5635-10 [00781563510]

Pioglitazone hydrochloride and glimepiride TABLET
Marketing CategoryANDA
Application NumberANDA201049
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-08

NDC 0781-5635-06 [00781563506]

Pioglitazone hydrochloride and glimepiride TABLET
Marketing CategoryANDA
Application NumberANDA201049
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-08
Marketing End Date2016-09-06

NDC 0781-5635-08 [00781563508]

Pioglitazone hydrochloride and glimepiride TABLET
Marketing CategoryANDA
Application NumberANDA201049
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-08
Marketing End Date2016-09-06

Drug Details

Active Ingredients

IngredientStrength
PIOGLITAZONE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:2aab19ce-1e5e-44ee-85e5-d8f125f9bb1a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 647239
  • 647237
  • UPC Code
  • 0307815635312
  • 0307815634315
  • 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]
    • Sulfonylurea [EPC]
    • Sulfonylurea Compounds [CS]

    NDC Crossover Matching brand name "Pioglitazone hydrochloride and glimepiride" or generic name "Pioglitazone Hydrochloride And Glimepiride"

    NDCBrand NameGeneric Name
    0781-5634Pioglitazone hydrochloride and glimepiridePioglitazone hydrochloride and glimepiride
    0781-5635Pioglitazone hydrochloride and glimepiridePioglitazone hydrochloride and glimepiride

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