Omeprazole

Product NDC
71713-201
11-digit product format
717130201
Labeler code
71713
Product ID
71713-201_b3d11bd8-0ac3-363e-2e46-03fc1366a56a
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Thirty Madison Inc
Application
ANDA207740
Marketing category
ANDA
Marketing start
2019-05-31
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71713-201-03EA - Each71713-20112b17266-8c8e-4ff4-b870-d6d65a9056fd12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71713-201OMEPRAZOLE TABLET, DELAYED RELEASE [THIRTY MADISON INC]3Legacy NDC20241030_b7289621-9dc7-fd2b-bbb1-f69dea450f7d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71713-201-01717130201011 BOTTLE in 1 CARTON (71713-201-01) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2019-05-310000-00-00NoNoCurrent
71713-201-03717130201033 BOTTLE in 1 CARTON (71713-201-03) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2019-05-310000-00-00NoNoCurrent