FDA.reportPublic FDA data

Prilosec OTC

Product NDC
37000-459
11-digit product format
370000459
Labeler code
37000
Product ID
37000-459_401e2c9f-fcc4-3d54-e063-6394a90a44e4
Type
HUMAN OTC DRUG
Nonproprietary name
OMEPRAZOLE MAGNESIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
NDA021229
Marketing category
NDA
Marketing start
2012-08-15
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
Prilosec OTC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK
Rxcui402014, 608796

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-459-012021-02-12C16284748780-1ba0f9c33-20c3-a910-e053-dadaa90a0b85Prilosec OTC® WILDBERRY
37000-459-022021-02-12C16284748780-1ba0f9c33-20c3-a910-e053-dadaa90a0b85Prilosec OTC® WILDBERRY
37000-459-032021-02-12C16284748780-1ba0f9c33-20c3-a910-e053-dadaa90a0b85Prilosec OTC® WILDBERRY
37000-459-042021-02-12C16284748780-1ba0f9c33-20c3-a910-e053-dadaa90a0b85Prilosec OTC® WILDBERRY
37000-459-052021-02-12C16284748780-1ba0f9c33-20c3-a910-e053-dadaa90a0b85Prilosec OTC® WILDBERRY
37000-459-012021-01-29C16284748780-1ba0f9c33-20c3-a910-e053-dadaa90a0b85Prilosec OTC® WILDBERRY
37000-459-022021-01-29C16284748780-1ba0f9c33-20c3-a910-e053-dadaa90a0b85Prilosec OTC® WILDBERRY
37000-459-032021-01-29C16284748780-1ba0f9c33-20c3-a910-e053-dadaa90a0b85Prilosec OTC® WILDBERRY
37000-459-042021-01-29C16284748780-1ba0f9c33-20c3-a910-e053-dadaa90a0b85Prilosec OTC® WILDBERRY
37000-459-052021-01-29C16284748780-1ba0f9c33-20c3-a910-e053-dadaa90a0b85Prilosec OTC® WILDBERRY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-459-01Prilosec OTC1 in 1 POUCHTABLET, DELAYED RELEASE117
37000-459-02Prilosec OTC14 in 1 CARTONTABLET, DELAYED RELEASE1417
37000-459-02Prilosec OTC1 in 1 BLISTER PACKTABLET, DELAYED RELEASE117
37000-459-03Prilosec OTC2 in 1 CARTONTABLET, DELAYED RELEASE217
37000-459-03Prilosec OTC14 in 1 CARTONTABLET, DELAYED RELEASE1417
37000-459-04Prilosec OTC14 in 1 CARTONTABLET, DELAYED RELEASE1417
37000-459-04Prilosec OTC3 in 1 CARTONTABLET, DELAYED RELEASE317
37000-459-05Prilosec OTC1 in 1 BLISTER PACKTABLET, DELAYED RELEASE117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-459-02EA - Each37000-459bfe87c2f-a3bb-4f43-bbd8-f49e931e921c12015-10-02
37000-459-03EA - Each37000-4599ac76b4b-e558-4228-85eb-68b0c1fbd23b12014-12-01
37000-459-04EA - Each37000-45971d027f7-e084-49a3-9a60-23f8abd4d57a12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLE MAGNESIUMACTIVE INGREDIENT426QFE7XLKPRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
OMEPRAZOLEACTIVE MOIETYKG60484QX9PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
MICAINACTIVE INGREDIENTV8A1AW0880PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIPRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
SUCROSEINACTIVE INGREDIENTC151H8M554PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
TALCINACTIVE INGREDIENT7SEV7J4R1UPRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-459PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]16Current NDC, Legacy NDC, 8 package rows20241012_35a79458-79f6-44d6-b74c-b4f4aaf0dde0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN35a79458-79f6-44d6-b74c-b4f4aaf0dde017
608796PriLOSEC OTC 20 MG Delayed Release Oral TabletPSN35a79458-79f6-44d6-b74c-b4f4aaf0dde017
608796omeprazole 20 MG Delayed Release Oral Tablet [Prilosec]SBD35a79458-79f6-44d6-b74c-b4f4aaf0dde017
402014omeprazole 20 MG Delayed Release Oral TabletSCD35a79458-79f6-44d6-b74c-b4f4aaf0dde017
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY35a79458-79f6-44d6-b74c-b4f4aaf0dde017
608796Prilosec 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY35a79458-79f6-44d6-b74c-b4f4aaf0dde017
608796Prilosec OTC 20 MG Delayed Release Oral TabletSY35a79458-79f6-44d6-b74c-b4f4aaf0dde017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-459-01370000459011 TABLET, DELAYED RELEASE in 1 POUCH (37000-459-01) 2012-08-150000-00-00NoNoCurrent
37000-459-023700004590214 BLISTER PACK in 1 CARTON (37000-459-02) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2012-08-150000-00-00NoNoCurrent
37000-459-03370000459032 CARTON in 1 CARTON (37000-459-03) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 carton2012-08-152022-12-01NoNoCurrent
37000-459-04370000459043 CARTON in 1 CARTON (37000-459-04) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2012-08-150000-00-00NoNoCurrent
37000-459-05370000459051 TABLET, DELAYED RELEASE in 1 BLISTER PACK (37000-459-05) 2012-08-150000-00-00NoNoCurrent