OMEPRAZOLE

Product NDC
68788-7898
11-digit product format
687887898
Labeler code
68788
Product ID
68788-7898_b5d39e9a-1687-42eb-bb7a-8b2dffdfb03e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203481
Marketing category
ANDA
Marketing start
2021-05-14
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7898-168788789801100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7898-1) 2021-05-140000-00-00NoNoCurrent
68788-7898-36878878980330 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7898-3) 2021-05-140000-00-00NoNoCurrent
68788-7898-66878878980660 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7898-6) 2021-05-140000-00-00NoNoCurrent
68788-7898-96878878980990 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7898-9) 2021-05-140000-00-00NoNoCurrent