Glipizide

Product NDC
68382-337
11-digit product format
683820337
Labeler code
68382
Product ID
68382-337_b7eb0015-2bd0-4e12-b35c-e63cd69c5c93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA203499
Marketing category
ANDA
Marketing start
2018-07-25
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
10 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-337-01EA - Each68382-3373ceed509-ced8-4dde-b8ec-a51610b3432812018-10-11
68382-337-05EA - Each68382-337b75ab38a-3f42-4ad6-a349-b559b59da86512018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-337-0168382033701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-337-01) 2018-07-250000-00-00NoNoCurrent
68382-337-0568382033705500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-337-05) 2018-07-250000-00-00NoNoCurrent
68382-337-066838203370630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-337-06) 2018-07-250000-00-00NoNoCurrent
68382-337-10683820337101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-337-10) 2018-07-250000-00-00NoNoCurrent
68382-337-146838203371460 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-337-14) 2018-07-250000-00-00NoNoCurrent
68382-337-166838203371690 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-337-16) 2018-07-250000-00-00NoNoCurrent
68382-337-776838203377710 BLISTER PACK in 1 CARTON (68382-337-77) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-337-30) 10 blister pack2018-07-250000-00-00NoNoCurrent