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 ID: 0781-5635_724cb72e-023e-409c-8979-3a380a2fdc0a
• NDC: 0781-5635
• Product Type: Human Prescription Drug
• Proprietary Name: Pioglitazone hydrochloride and glimepiride
• Generic Name: Pioglitazone Hydrochloride And Glimepiride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-01-08
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201049
• Labeler Name: Sandoz Inc
• Substance Name: PIOGLITAZONE HYDROCHLORIDE; GLIMEPIRIDE
• Active Ingredient Strength: 30 mg/1; mg/1
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0781-5635-10

1000 TABLET in 1 BOTTLE (0781-5635-10)

• Marketing Start Date: 2013-01-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-5635-31 [00781563531]

Pioglitazone hydrochloride and glimepiride TABLET

• Marketing Category: ANDA
• Application Number: ANDA201049
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-08

NDC 0781-5635-10 [00781563510]

Pioglitazone hydrochloride and glimepiride TABLET

• Marketing Category: ANDA
• Application Number: ANDA201049
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-08

NDC 0781-5635-06 [00781563506]

Pioglitazone hydrochloride and glimepiride TABLET

• Marketing Category: ANDA
• Application Number: ANDA201049
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-08
• Marketing End Date: 2016-09-06

NDC 0781-5635-08 [00781563508]

Pioglitazone hydrochloride and glimepiride TABLET

• Marketing Category: ANDA
• Application Number: ANDA201049
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-08
• Marketing End Date: 2016-09-06

Drug Details

Active Ingredients

Ingredient	Strength
PIOGLITAZONE HYDROCHLORIDE	30 mg/1

OpenFDA Data

• SPL SET ID: 2aab19ce-1e5e-44ee-85e5-d8f125f9bb1a
• Manufacturer:
  • Sandoz Inc
• UNII:
  • JQT35NPK6C
  • 6KY687524K
• 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"

NDC	Brand Name	Generic Name
0781-5634	Pioglitazone hydrochloride and glimepiride	Pioglitazone hydrochloride and glimepiride
0781-5635	Pioglitazone hydrochloride and glimepiride	Pioglitazone hydrochloride and glimepiride