FDA.reportPublic FDA data

OMEPRAZOLE

Product NDC
51407-664
11-digit product format
514070664
Labeler code
51407
Product ID
51407-664_4f745e3f-7028-51ec-e063-6294a90af7af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA203481
Marketing category
ANDA
Marketing start
2017-07-03
Marketing end
2027-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OMEPRAZOLE

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-664-00OMEPRAZOLE50000 in 1 DRUMCAPSULE, DELAYED RELEASE PELLETS500005
51407-664-01OMEPRAZOLE100 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS1005
51407-664-05OMEPRAZOLE500 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-664-01EA - Each51407-664e8ba06b2-9569-469f-9ec9-85505fdd13ee12023-02-06
51407-664-05EA - Each51407-6640111dc10-cec6-49d0-87bb-9034c676f3d912023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-664OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]3Current NDC, 3 package rows20240809_f27b3518-d5c1-1229-e053-2a95a90ab56f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNf27b3518-d5c1-1229-e053-2a95a90ab56f5
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDf27b3518-d5c1-1229-e053-2a95a90ab56f5
200329omeprazole 40 MG Delayed Release Oral CapsulePSN3e99b78b-7fb8-4514-a3db-58e59cd429d82
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD3e99b78b-7fb8-4514-a3db-58e59cd429d82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-664-005140706640050000 in 1 DRUMHistorical
51407-664-0151407066401100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-664-01) 2022-07-152027-01-31NoNoHistorical
51407-664-0551407066405500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-664-05) 2023-01-032027-01-31NoNoHistorical