FDA.reportPublic FDA data

Omeprazole

Product NDC
71335-9609
11-digit product format
713359609
Labeler code
71335
Product ID
71335-9609_d1a8c9e3-3ac2-476e-8a48-e117af47837d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075757
Marketing category
ANDA
Marketing start
2019-07-01
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9609-0Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE7104
71335-9609-1Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE30104
71335-9609-2Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE60104
71335-9609-3Omeprazole56 in 1 BOTTLECAPSULE, DELAYED RELEASE56104
71335-9609-4Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE90104
71335-9609-5Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE20104
71335-9609-6Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE15104
71335-9609-7Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE120104
71335-9609-8Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE100104
71335-9609-9Omeprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE28104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9609-1EA - Each71335-960909f8e273-b14d-4f47-ad0a-106fe8e2536712023-08-08
71335-9609-2EA - Each71335-96097dde5f6e-b577-4ecd-9b8b-f715c242039412023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9609OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240809_17664f71-154a-47c6-b83c-b349bbc8a98f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN17664f71-154a-47c6-b83c-b349bbc8a98f104
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD17664f71-154a-47c6-b83c-b349bbc8a98f104
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY17664f71-154a-47c6-b83c-b349bbc8a98f104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-9609-0713359609007 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-0) 2024-04-030000-00-00NoNoCurrent
71335-9609-17133596090130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-1) 2023-01-250000-00-00NoNoCurrent
71335-9609-27133596090260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-2) 2022-12-290000-00-00NoNoCurrent
71335-9609-37133596090356 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-3) 2024-04-030000-00-00NoNoCurrent
71335-9609-47133596090490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-4) 2023-02-140000-00-00NoNoCurrent
71335-9609-57133596090520 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-5) 2024-04-030000-00-00NoNoCurrent
71335-9609-67133596090615 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-6) 2023-04-280000-00-00NoNoCurrent
71335-9609-771335960907120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-7) 2022-12-150000-00-00NoNoCurrent
71335-9609-871335960908100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-8) 2024-04-030000-00-00NoNoCurrent
71335-9609-97133596090928 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-9) 2024-04-030000-00-00NoNoCurrent