Candesartan cilexetil

Product NDC
68382-192
11-digit product format
683820192
Labeler code
68382
Product ID
68382-192_da3d5c58-fa7e-45a0-87fe-baa52e23a3fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Candesartan cilexetil
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA091390
Marketing category
ANDA
Marketing start
2018-02-22
Marketing end
0000-00-00
Substance
CANDESARTAN CILEXETIL
Active strength
16 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-192-0168382019201100 TABLET in 1 BOTTLE (68382-192-01) 100 tablet2018-02-220000-00-00NoNoCurrent
68382-192-0568382019205500 TABLET in 1 BOTTLE (68382-192-05) 500 tablet2018-02-220000-00-00NoNoCurrent
68382-192-066838201920630 TABLET in 1 BOTTLE (68382-192-06) 30 tablet2018-02-220000-00-00NoNoCurrent
68382-192-10683820192101000 TABLET in 1 BOTTLE (68382-192-10) 1000 tablet2018-02-220000-00-00NoNoCurrent
68382-192-166838201921690 TABLET in 1 BOTTLE (68382-192-16) 90 tablet2018-02-220000-00-00NoNoCurrent