NDC 0378-1575

Pioglitazone Hydrochloride and Metformin Hydrochloride

Pioglitazone Hydrochloride And Metformin Hydrochloride

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

• Product ID: 0378-1575_4229b266-ce42-45af-b41b-0426f025179b
• NDC: 0378-1575
• Product Type: Human Prescription Drug
• Proprietary Name: Pioglitazone Hydrochloride and Metformin Hydrochloride
• Generic Name: Pioglitazone Hydrochloride And Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-08-17
• Marketing End Date: 2019-06-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090406
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 15 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],Biguanide [EPC],Biguanides [CS]
• NDC Exclude Flag: N

Packaging

NDC 0378-1575-91

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1575-91)

• Marketing Start Date: 2012-08-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-1575-91 [00378157591]

Pioglitazone Hydrochloride and Metformin Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090406
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-08-17
• Marketing End Date: 2019-06-30

NDC 0378-1575-80 [00378157580]

Pioglitazone Hydrochloride and Metformin Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090406
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-08-17
• Marketing End Date: 2014-11-25

NDC 0378-1575-05 [00378157505]

Pioglitazone Hydrochloride and Metformin Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090406
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-08-17
• Marketing End Date: 2014-11-25

Drug Details

Active Ingredients

Ingredient	Strength
PIOGLITAZONE HYDROCHLORIDE	15 mg/1

OpenFDA Data

• SPL SET ID: 91385f6c-ba70-4247-88f4-5f3b25ddd6b3
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • JQT35NPK6C
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 861783
  • 861822
• UPC Code:
  • 0303781550918
  • 0303781575911

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 Hydrochloride and Metformin Hydrochloride" or generic name "Pioglitazone Hydrochloride And Metformin Hydrochloride"

NDC	Brand Name	Generic Name
0378-1550	Pioglitazone Hydrochloride and Metformin Hydrochloride	pioglitazone hydrochloride and metformin hydrochloride
0378-1575	Pioglitazone Hydrochloride and Metformin Hydrochloride	pioglitazone hydrochloride and metformin hydrochloride
57237-217	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride
57237-218	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride
65862-525	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride
65862-526	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride