Omeprazole

Product NDC
50268-620
11-digit product format
502680620
Labeler code
50268
Product ID
50268-620_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
2011-07-11
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
40 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
50268-620-152022-01-31C16284748780-1d6a99b39-834f-a426-e053-dadaa90af4c204d9fe8b-6d44-f46f-732a-5583a7118b91
50268-620-152022-01-28C16284748780-1d6a99b39-834f-a426-e053-dadaa90af4c204d9fe8b-6d44-f46f-732a-5583a7118b91

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-620-11EA - Each50268-62037ae402c-9ad5-436e-b3a9-eed5c5cb7f6812015-05-05
50268-620-15EA - Each50268-6201420aba8-097b-4a62-bfdf-a387487a09cb12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-620-155026806201550 BLISTER PACK in 1 BOX (50268-620-15) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (50268-620-11) 50 blister pack2011-07-110000-00-00NoNoCurrent