FDA.reportPublic FDA data

Omeprazole

Product NDC
51407-813
11-digit product format
514070813
Labeler code
51407
Product ID
51407-813_3ba5e1e5-159d-2492-e063-6294a90a6c8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA212977
Marketing category
ANDA
Marketing start
2020-12-10
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, 200329

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-813-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1007
51407-813-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10007
51407-813-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
51407-813-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-813-01EA - Each51407-813ff8e2772-0d1e-4684-875f-0c0d16d9d3e312024-05-16
51407-813-10EA - Each51407-8131472ae74-9df5-4dc5-8843-00a54bda0be012024-05-16
51407-813-30EA - Each51407-813eca9b17f-668f-4d53-b61e-1c02b2d26a3712024-05-16
51407-813-90EA - Each51407-81317e98bfd-a649-4033-b955-eec5ce1087f912024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-813OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]6Current NDC, 4 package rows20250501_ded71262-d17f-3799-e053-2995a90a5427.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNded71262-d17f-3799-e053-2995a90a54277
200329omeprazole 40 MG Delayed Release Oral CapsulePSNded71262-d17f-3799-e053-2995a90a54277
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDded71262-d17f-3799-e053-2995a90a54277
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDded71262-d17f-3799-e053-2995a90a54277
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYded71262-d17f-3799-e053-2995a90a54277

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-813-0151407081301100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-813-01) 2024-03-19NoNoCurrent
51407-813-10514070813101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-813-10) 2024-03-19NoNoCurrent
51407-813-305140708133030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-813-30) 2024-03-19NoNoCurrent
51407-813-905140708139090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-813-90) 2024-03-19NoNoCurrent