FDA.reportPublic FDA data

Omeprazole 20 mg

Product NDC
25000-091
11-digit product format
250000091
Labeler code
25000
Product ID
25000-091_dcf79426-6aec-432a-aabe-dcb98c0f2cec
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole 20 mg
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA218829
Marketing category
ANDA
Marketing start
2025-08-12
Substance
OMEPRAZOLE MAGNESIUM
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 20 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25000-091-76Omeprazole 20 mg1 in 1 CARTONTABLET, DELAYED RELEASE13
25000-091-76Omeprazole 20 mg14 in 1 BOTTLETABLET, DELAYED RELEASE143
25000-091-77Omeprazole 20 mg7 in 1 BLISTER PACKTABLET, DELAYED RELEASE73
25000-091-77Omeprazole 20 mg2 in 1 CARTONTABLET, DELAYED RELEASE23

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN921bf750-9dd7-42ff-82bb-043b03f0fe693
402014omeprazole 20 MG Delayed Release Oral TabletSCD921bf750-9dd7-42ff-82bb-043b03f0fe693
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY921bf750-9dd7-42ff-82bb-043b03f0fe693

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25000-091-76250000091761 BOTTLE in 1 CARTON (25000-091-76) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2025-08-12NoNoHistorical
25000-091-77250000091772 BLISTER PACK in 1 CARTON (25000-091-77) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2025-08-12NoNoHistorical