FDA.reportPublic FDA data

Omeprazole

Product NDC
71335-1852
11-digit product format
713351852
Labeler code
71335
Product ID
71335-1852_47164bbb-a6dc-4abe-9ca5-51832dde606c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203270
Marketing category
ANDA
Marketing start
2015-08-19
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1852-0Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE7107
71335-1852-1Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE30107
71335-1852-2Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE60107
71335-1852-3Omeprazole56 in 1 BOTTLECAPSULE, DELAYED RELEASE56107
71335-1852-4Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE90107
71335-1852-5Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE20107
71335-1852-6Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE15107
71335-1852-7Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE120107
71335-1852-8Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE100107
71335-1852-9Omeprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE28107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1852-1EA - Each71335-18525fb515f0-1403-4ef5-853d-d3612ed5eca512021-08-05
71335-1852-2EA - Each71335-185203709a20-2853-490c-9fa8-2efed5f1c8c012021-08-05
71335-1852-3EA - Each71335-1852f2fff104-177d-418b-be32-463a12a457fc12021-08-05
71335-1852-4EA - Each71335-1852e7ed652e-cfa0-4b87-82fe-1b48e5a9082912021-08-05
71335-1852-6EA - Each71335-18528f90f35f-9266-4c71-95d3-84f53efcb3b212021-08-05
71335-1852-7EA - Each71335-1852950ee240-ad15-4983-aae9-c1ec9863239212021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1852OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 10 package rows20241225_064b1418-0f42-4b18-9dee-cda40c5e1fca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN064b1418-0f42-4b18-9dee-cda40c5e1fca107
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD064b1418-0f42-4b18-9dee-cda40c5e1fca107
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY064b1418-0f42-4b18-9dee-cda40c5e1fca107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1852-0713351852007 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1852-0) 2024-12-110000-00-00NoNoCurrent
71335-1852-17133518520130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1852-1) 2021-05-140000-00-00NoNoCurrent
71335-1852-27133518520260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1852-2) 2021-05-180000-00-00NoNoCurrent
71335-1852-37133518520356 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1852-3) 2024-12-110000-00-00NoNoCurrent
71335-1852-47133518520490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1852-4) 2021-05-280000-00-00NoNoCurrent
71335-1852-57133518520520 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1852-5) 2021-10-140000-00-00NoNoCurrent
71335-1852-67133518520615 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1852-6) 2021-05-210000-00-00NoNoCurrent
71335-1852-771335185207120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1852-7) 2021-06-210000-00-00NoNoCurrent
71335-1852-871335185208100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1852-8) 2021-12-220000-00-00NoNoCurrent
71335-1852-97133518520928 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1852-9) 2024-12-110000-00-00NoNoCurrent