FDA.reportPublic FDA data

Omeprazole

Product NDC
70677-0148
11-digit product format
706770148
Labeler code
70677
Product ID
70677-0148_b4a9538c-049e-45d3-8b28-581c68a36ed6
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Strategic Sourcing Services
Application
ANDA207891
Marketing category
ANDA
Marketing start
2019-01-01
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
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
70677-0148-1Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE11
70677-0148-1Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0148-1EA - Each70677-01489964fbdd-9622-4cac-8a91-d67f6775db9212022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0148OMEPRAZOLE TABLET, DELAYED RELEASE [STRATEGIC SOURCING SERVICES]1Current NDC, Legacy NDC, 2 package rows20220514_dfa91081-3917-4dfc-9789-76800f57bb31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNdfa91081-3917-4dfc-9789-76800f57bb311
402014omeprazole 20 MG Delayed Release Oral TabletSCDdfa91081-3917-4dfc-9789-76800f57bb311
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYdfa91081-3917-4dfc-9789-76800f57bb311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70677-0148-1706770148011 BLISTER PACK in 1 CARTON (70677-0148-1) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2019-01-010000-00-00NoNoCurrent