Omeprazole

Product NDC
50268-619
11-digit product format
502680619
Labeler code
50268
Product ID
50268-619_90cf2a57-479c-4250-b64b-874726a7170a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA075410
Marketing category
ANDA
Marketing start
2011-07-12
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50268-619-152022-01-31C16284748780-1d6a99b39-834f-a426-e053-dadaa90af4c204d9fe8b-6d44-f46f-732a-5583a7118b91
50268-619-152022-01-28C16284748780-1d6a99b39-834f-a426-e053-dadaa90af4c204d9fe8b-6d44-f46f-732a-5583a7118b91

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-619-11EA - Each50268-61997c18daf-0c85-4557-af27-9eee973ce94612015-05-05
50268-619-15EA - Each50268-619f0b376fc-7c54-4d0a-a5af-f1456d5b9abb12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-619-155026806191550 BLISTER PACK in 1 BOX (50268-619-15) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (50268-619-11) 50 blister pack2011-07-120000-00-00NoNoCurrent