NDC 68382-308

pioglitazone

Pioglitazone

pioglitazone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Pioglitazone Hydrochloride.

Product ID68382-308_16e816dd-13f7-4e4d-a58a-6d2e6090b0d2
NDC68382-308
Product TypeHuman Prescription Drug
Proprietary Namepioglitazone
Generic NamePioglitazone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-11-16
Marketing CategoryANDA / ANDA
Application NumberANDA202456
Labeler NameZydus Pharmaceuticals USA Inc.
Substance NamePIOGLITAZONE HYDROCHLORIDE
Active Ingredient Strength45 mg/1
Pharm ClassesPPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68382-308-01

100 TABLET in 1 BOTTLE (68382-308-01)
Marketing Start Date2016-11-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-308-10 [68382030810]

pioglitazone TABLET
Marketing CategoryANDA
Application NumberANDA202456
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-16

NDC 68382-308-05 [68382030805]

pioglitazone TABLET
Marketing CategoryANDA
Application NumberANDA202456
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-16

NDC 68382-308-16 [68382030816]

pioglitazone TABLET
Marketing CategoryANDA
Application NumberANDA202456
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-16

NDC 68382-308-30 [68382030830]

pioglitazone TABLET
Marketing CategoryANDA
Application NumberANDA202456
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-16

NDC 68382-308-77 [68382030877]

pioglitazone TABLET
Marketing CategoryANDA
Application NumberANDA202456
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-16

NDC 68382-308-01 [68382030801]

pioglitazone TABLET
Marketing CategoryANDA
Application NumberANDA202456
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-16

NDC 68382-308-06 [68382030806]

pioglitazone TABLET
Marketing CategoryANDA
Application NumberANDA202456
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-16

Drug Details

Active Ingredients

IngredientStrength
PIOGLITAZONE HYDROCHLORIDE45 mg/1

OpenFDA Data

SPL SET ID:e102b8cd-d630-4602-8dd4-c851bf9ee39c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312440
  • 312441
  • 317573
    • UPC Code
  • 0368382308061
  • 0368382306067

    • 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]

    NDC Crossover Matching brand name "pioglitazone" or generic name "Pioglitazone"

    NDCBrand NameGeneric Name
    0093-7271PioglitazonePioglitazone
    0093-7272PioglitazonePioglitazone
    0093-7273PioglitazonePioglitazone
    0378-0048Pioglitazonepioglitazone
    0378-0228Pioglitazonepioglitazone
    0378-0318Pioglitazonepioglitazone
    0781-5420Pioglitazonepioglitazone
    0781-5421Pioglitazonepioglitazone
    0781-5422Pioglitazonepioglitazone
    0904-7090PioglitazonePioglitazone
    0904-7096PioglitazonePioglitazone
    16714-645PioglitazonePioglitazone
    16714-646PioglitazonePioglitazone
    16714-647PioglitazonePioglitazone
    16729-020PIOGLITAZONEPIOGLITAZONE
    68071-1621PioglitazonePioglitazone
    68151-3798PioglitazonePioglitazone
    68151-3792PioglitazonePioglitazone
    68382-308pioglitazonepioglitazone
    68382-306pioglitazonepioglitazone
    68382-307pioglitazonepioglitazone
    70518-1815PioglitazonePioglitazone
    70771-1023pioglitazonepioglitazone
    70771-1021pioglitazonepioglitazone
    70771-1022pioglitazonepioglitazone
    71335-0088PioglitazonePioglitazone
    16729-021PIOGLITAZONEPIOGLITAZONE
    16729-022PIOGLITAZONEPIOGLITAZONE
    33342-054PioglitazonePioglitazone
    33342-056PioglitazonePioglitazone
    33342-055PioglitazonePioglitazone
    43547-426PIOGLITAZONEPIOGLITAZONE
    43547-428PIOGLITAZONEPIOGLITAZONE
    43547-427PIOGLITAZONEPIOGLITAZONE
    50090-2637PioglitazonePioglitazone
    50090-2390PioglitazonePioglitazone
    51079-513PioglitazonePioglitazone
    51079-515PioglitazonePioglitazone
    51079-514PioglitazonePioglitazone
    54458-864PioglitazonePioglitazone
    54458-866PioglitazonePioglitazone
    54458-885PioglitazonePioglitazone
    54458-865PioglitazonePioglitazone
    54458-884PioglitazonePioglitazone
    55648-977PioglitazonePioglitazone
    55648-976PioglitazonePioglitazone
    55648-978PioglitazonePioglitazone
    57237-219PioglitazonePioglitazone
    57237-221PioglitazonePioglitazone
    57237-220PioglitazonePioglitazone
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