OMEPRAZOLE

Product NDC
68788-7896
11-digit product format
687887896
Labeler code
68788
Product ID
68788-7896_b61cd65c-26a9-4a57-9895-cbf463f1e411
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA203481
Marketing category
ANDA
Marketing start
2021-04-30
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7896-1EA - Each68788-78966901a0af-77ed-464d-862a-82f4b05dc55612021-06-02
68788-7896-3EA - Each68788-7896c524e859-91fe-4e1a-bb3a-e6be8b93993e12021-06-02
68788-7896-6EA - Each68788-789674601da4-6484-46f1-90de-ebb84730654b12021-06-02
68788-7896-8EA - Each68788-7896b13cb7f4-0d45-4c5d-b79b-5e619ef0bacd12021-06-02
68788-7896-9EA - Each68788-78961f5b8b09-d7ad-4d93-84b9-a3efe0025ec112021-06-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7896-168788789601100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7896-1) 2021-04-300000-00-00NoNoCurrent
68788-7896-36878878960330 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7896-3) 2021-04-300000-00-00NoNoCurrent
68788-7896-66878878960660 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7896-6) 2021-04-300000-00-00NoNoCurrent
68788-7896-868788789608120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7896-8) 2021-04-300000-00-00NoNoCurrent
68788-7896-96878878960990 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7896-9) 2021-04-300000-00-00NoNoCurrent