FDA.reportPublic FDA data

OMEPRAZOLE

Product NDC
51407-814
11-digit product format
514070814
Labeler code
51407
Product ID
51407-814_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
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OMEPRAZOLE
Listing expiration
2027-12-31

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
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
51407-814-01OMEPRAZOLE100 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS1005
51407-814-05OMEPRAZOLE500 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS5005
51407-814-30OMEPRAZOLE30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS305
51407-814-90OMEPRAZOLE90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-814-01EA - Each51407-8141ed69f17-1994-4635-87d4-4ea1cae0b45a12024-05-16
51407-814-05EA - Each51407-81471f91dba-fc37-441e-9dba-7c3de5cc89cd12024-05-16
51407-814-30EA - Each51407-814a7e00fdb-5777-4d85-87fe-f0d9487b53a412024-05-16
51407-814-90EA - Each51407-814a674ed54-345b-4980-b134-16f1ae7222ef12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-814OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]3Current NDC, 4 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-814-0151407081401100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-01) 2024-03-19NoNoHistorical
51407-814-0551407081405500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-05) 2024-03-19NoNoHistorical
51407-814-305140708143030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-30) 2024-03-19NoNoHistorical
51407-814-905140708149090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-814-90) 2024-03-19NoNoHistorical