Pioglitazone hydrochloride and glimepiride

Product NDC
0781-5635
11-digit product format
007815635
Labeler code
0781
Product ID
0781-5635_724cb72e-023e-409c-8979-3a380a2fdc0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone hydrochloride and glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA201049
Marketing category
ANDA
Marketing start
2013-01-08
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE; GLIMEPIRIDE
Active strength
30 mg/1; mg/1
Pharmacologic 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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-5635-10007815635101000 TABLET in 1 BOTTLE (0781-5635-10) 1000 tablet2013-01-080000-00-00NoNoCurrent
0781-5635-310078156353130 TABLET in 1 BOTTLE (0781-5635-31) 30 tablet2013-01-080000-00-00NoNoCurrent