FDA.reportPublic FDA data

Omeprazole

Product NDC
35356-811
11-digit product format
353560811
Labeler code
35356
Product ID
35356-811_76b8332f-f336-4e78-a721-ba9fd2aceccb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA075876
Marketing category
ANDA
Marketing start
2011-01-14
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-811-14EA - Each35356-811830a109b-9e16-40b0-a989-7c35b6e064af12017-09-11
35356-811-30EA - Each35356-811556e5fb5-b1cc-4660-8f89-314af5587b0c12013-02-13
35356-811-60EA - Each35356-8110e6956df-2228-4a3e-87d5-4bf91d3d524012017-09-11
35356-811-90EA - Each35356-811d02ff8bb-05c5-4f91-b603-33d6bfec86d612017-09-11