Omeprazole

Product NDC
68071-2358
11-digit product format
680712358
Labeler code
68071
Product ID
68071-2358_bd1f6488-e68d-3ef2-e053-2a95a90a9cb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA075410
Marketing category
ANDA
Marketing start
2002-11-04
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2358-1Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2358OMEPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20210310_bd1f6488-e68c-3ef2-e053-2a95a90a9cb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNbd1f6488-e68c-3ef2-e053-2a95a90a9cb31
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDbd1f6488-e68c-3ef2-e053-2a95a90a9cb31
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYbd1f6488-e68c-3ef2-e053-2a95a90a9cb31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2358-168071235801100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2358-1) 2021-03-090000-00-00NoNoCurrent