Omeprazole

Product NDC
63739-358
11-digit product format
637390358
Labeler code
63739
Product ID
63739-358_b3b0f9be-039d-fcc1-e053-2995a90a98d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA075410
Marketing category
ANDA
Marketing start
2002-11-04
Marketing end
2021-08-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-358-102020-07-22C16284748780-1ab0e2407-2b7e-f274-e053-dbdaa90a64710dc9682c-a4ae-4786-8dd9-31e33ce9861b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-358-10EA - Each63739-358fa286871-3df4-4688-a516-6002bd6601be12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-358-106373903581010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-358-10) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2016-08-222021-08-31NoNoCurrent