FDA.reportPublic FDA data

Omeprazole

Product NDC
70677-1098
11-digit product format
706771098
Labeler code
70677
Product ID
70677-1098_252eeb77-6319-49df-9259-fcf2f917b2b5
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
STRATEGIC SOURCING SERVICES LLC
Application
ANDA207891
Marketing category
ANDA
Marketing start
2023-08-11
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
Rxcui402014

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
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1098-1Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE11
70677-1098-1Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1098-1EA - Each70677-1098a14c8789-f362-4ff4-8371-f32745d43e2c12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1098OMEPRAZOLE TABLET, DELAYED RELEASE [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 2 package rows20230817_56380ccc-6fc2-4e1b-bd87-da24c9aa31cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN56380ccc-6fc2-4e1b-bd87-da24c9aa31cd1
402014omeprazole 20 MG Delayed Release Oral TabletSCD56380ccc-6fc2-4e1b-bd87-da24c9aa31cd1
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY56380ccc-6fc2-4e1b-bd87-da24c9aa31cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1098-1706771098011 BLISTER PACK in 1 CARTON (70677-1098-1) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2023-08-11NoNoHistorical