FDA.reportPublic FDA data

Omeprazole

Product NDC
71335-0299
11-digit product format
713350299
Labeler code
71335
Product ID
71335-0299_b0b2453e-a5f6-4ad9-a113-720f562d0c7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
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
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
71335-0299-1Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE6020
71335-0299-2Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3020
71335-0299-3Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE2020
71335-0299-4Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9020
71335-0299-5Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE1420
71335-0299-6Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE12020
71335-0299-7Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10020
71335-0299-8Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE18020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0299-1EA - Each71335-02991cbcc640-c1cf-438b-bcbb-eecc0d5c33ae12018-03-08
71335-0299-2EA - Each71335-029945bf7c9b-7b4c-4f96-82d1-ac5fa31edeb912018-03-08
71335-0299-3EA - Each71335-0299e96bee5c-8202-42c6-8811-8e45d9f7c81912018-03-08
71335-0299-4EA - Each71335-0299eccc70e0-c9d5-4b70-93b9-60e4c13854a912018-03-08
71335-0299-5EA - Each71335-02997dcb5521-6d03-4683-95ca-c89196f7b64512018-03-08
71335-0299-6EA - Each71335-02993c0367f9-a47a-4cd7-8d86-8bba4256979012018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0299OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]20Current NDC, Legacy NDC, 8 package rows20240809_2b7491dd-19f5-42e0-b901-7ba71a3820c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN2b7491dd-19f5-42e0-b901-7ba71a3820c720
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD2b7491dd-19f5-42e0-b901-7ba71a3820c720

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0299-17133502990160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0299-1) 2018-03-210000-00-00NoNoCurrent
71335-0299-27133502990230 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0299-2) 2018-03-220000-00-00NoNoCurrent
71335-0299-37133502990320 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0299-3) 2018-11-050000-00-00NoNoCurrent
71335-0299-47133502990490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0299-4) 2018-05-010000-00-00NoNoCurrent
71335-0299-57133502990514 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0299-5) 2018-05-110000-00-00NoNoCurrent
71335-0299-671335029906120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0299-6) 2022-05-020000-00-00NoNoCurrent
71335-0299-771335029907100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0299-7) 2020-10-140000-00-00NoNoCurrent
71335-0299-871335029908180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0299-8) 2022-05-020000-00-00NoNoCurrent