NDC 0781-5627

Pioglitazone and metformin

Pioglitazone And Metformin

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

• Product ID: 0781-5627_5cec9e36-fcdf-4d56-9305-2b57fca0bb41
• NDC: 0781-5627
• Product Type: Human Prescription Drug
• Proprietary Name: Pioglitazone and metformin
• Generic Name: Pioglitazone And Metformin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-05-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091273
• Labeler Name: Sandoz 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
• Listing Certified Through: 2019-12-31

Packaging

NDC 0781-5627-06

5 TABLET, FILM COATED in 1 BLISTER PACK (0781-5627-06)

• Marketing Start Date: 2013-05-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-5627-66 [00781562766]

Pioglitazone and metformin TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA091273
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-05-02

NDC 0781-5627-06 [00781562706]

Pioglitazone and metformin TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA091273
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-05-02

NDC 0781-5627-60 [00781562760]

Pioglitazone and metformin TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA091273
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-05-02

Drug Details

Active Ingredients

Ingredient	Strength
PIOGLITAZONE HYDROCHLORIDE	15 mg/1

OpenFDA Data

• SPL SET ID: 171a41f7-da5a-4a55-bd0e-40a29977b2e5
• Manufacturer:
  • Sandoz Inc
• UNII:
  • JQT35NPK6C
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 861783
  • 861822
• UPC Code:
  • 0307815626600
  • 0307815627607

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" or generic name "Pioglitazone And Metformin"

NDC	Brand Name	Generic Name
0781-5626	Pioglitazone and metformin	Pioglitazone and metformin
0781-5627	Pioglitazone and metformin	Pioglitazone and metformin
70882-105	Pioglitazone and metformin	Pioglitazone and metformin