FDA.reportPublic FDA data

Omeprazole

Product NDC
71335-1532
11-digit product format
713351532
Labeler code
71335
Product ID
71335-1532_2d8d7573-8196-4fb8-bd73-351c763c5fd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075410
Marketing category
ANDA
Marketing start
2009-01-23
Substance
OMEPRAZOLE
Active strength
40 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
OMEPRAZOLE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui200329

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1532-1Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE605
71335-1532-2Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
71335-1532-3Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE205
71335-1532-4Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE905
71335-1532-5Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
71335-1532-6Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1205
71335-1532-7Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1005
71335-1532-8Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1532-1EA - Each71335-1532ddfccac4-2a98-492a-a79d-8a52797ff4eb12022-09-12
71335-1532-2EA - Each71335-1532cca7401d-8fb9-4ca2-a390-13e1078e09ca12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1532OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 8 package rows20240526_1318a1c1-222d-471a-92d6-3632c82fb999.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN1318a1c1-222d-471a-92d6-3632c82fb9995
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD1318a1c1-222d-471a-92d6-3632c82fb9995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1532-17133515320160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-1) 2020-03-130000-00-00NoNoCurrent
71335-1532-27133515320230 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-2) 2020-03-170000-00-00NoNoCurrent
71335-1532-37133515320320 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-3) 2022-03-100000-00-00NoNoCurrent
71335-1532-47133515320490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-4) 2020-04-240000-00-00NoNoCurrent
71335-1532-57133515320514 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-5) 2020-03-160000-00-00NoNoCurrent
71335-1532-671335153206120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-6) 2022-03-100000-00-00NoNoCurrent
71335-1532-771335153207100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-7) 2021-03-010000-00-00NoNoCurrent
71335-1532-871335153208180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-8) 2022-03-100000-00-00NoNoCurrent