Omeprazole

Product NDC
63739-445
11-digit product format
637390445
Labeler code
63739
Product ID
63739-445_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
2009-01-23
Marketing end
2021-03-31
Substance
OMEPRAZOLE
Active strength
40 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
63739-445-102020-07-22C16284748780-1ab0e2407-2b7e-f274-e053-dbdaa90a64710dc9682c-a4ae-4786-8dd9-31e33ce9861b
63739-445-432020-07-22C16284748780-1ab0e2407-2b7e-f274-e053-dbdaa90a64710dc9682c-a4ae-4786-8dd9-31e33ce9861b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-445-10EA - Each63739-4458f34dfc0-52b0-4c04-bf56-40add71d5b3b12012-07-24
63739-445-43EA - Each63739-44572765ce7-26fc-4eb5-a4cb-3e1d0b136f9112019-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-445-106373904451010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-445-10) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2016-08-222021-03-31NoNoCurrent