FDA.reportPublic FDA data

Prilosec OTC

Product NDC
84126-301
11-digit product format
841260301
Labeler code
84126
Product ID
84126-301_3737e19c-a9b1-a1f8-e063-6394a90aace8
Type
HUMAN OTC DRUG
Nonproprietary name
OMEPRAZOLE MAGNESIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
ANDA206582
Marketing category
ANDA
Marketing start
2025-06-03
Substance
OMEPRAZOLE MAGNESIUM
Active strength
20.6 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
Prilosec OTC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE MAGNESIUM20.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK
Rxcui402014, 608796

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-301-14Prilosec OTC1 in 1 CARTONTABLET, DELAYED RELEASE12
84126-301-14Prilosec OTC14 in 1 BLISTER PACKTABLET, DELAYED RELEASE142
84126-301-42Prilosec OTC3 in 1 CARTONTABLET, DELAYED RELEASE32
84126-301-42Prilosec OTC14 in 1 BLISTER PACKTABLET, DELAYED RELEASE142

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNc7229a69-07e7-4690-8fc0-1f0f093bf2302
608796PriLOSEC OTC 20 MG Delayed Release Oral TabletPSNc7229a69-07e7-4690-8fc0-1f0f093bf2302
608796omeprazole 20 MG Delayed Release Oral Tablet [Prilosec]SBDc7229a69-07e7-4690-8fc0-1f0f093bf2302
402014omeprazole 20 MG Delayed Release Oral TabletSCDc7229a69-07e7-4690-8fc0-1f0f093bf2302
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYc7229a69-07e7-4690-8fc0-1f0f093bf2302
608796Prilosec 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYc7229a69-07e7-4690-8fc0-1f0f093bf2302
608796Prilosec OTC 20 MG Delayed Release Oral TabletSYc7229a69-07e7-4690-8fc0-1f0f093bf2302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-301-14841260301141 BLISTER PACK in 1 CARTON (84126-301-14) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2025-06-03NoNoHistorical
84126-301-42841260301423 BLISTER PACK in 1 CARTON (84126-301-42) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 blister pack2025-06-03NoNoHistorical