Prilosec OTC

Product NDC
37000-459
Requested package NDC
37000-459-01
11-digit product format
370000459
Labeler code
37000
Product ID
37000-459_5d19143c-93be-ae16-e063-6294a90a19a6
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021229-001PRILOSEC OTCOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-2084e616aacf4f…
2026-08-18 06:07:402026-07N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-2087673890dc5c…
2021-03-12 10:30 UTC2021-03N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-203f01610625f2…
2019-09-15 20:21 UTC2019-09N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20b00525d2431f…
2019-07-19 19:46 UTC2019-07N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-203f0d92c62455…
2023-05-13 08:27 UTC2023-05N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20053a50430f4f…
2023-01-26 05:58 UTC2023-01N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20f41ea6bd6efb…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021229-00164288102019-11-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021229-00164036162019-11-1574a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021229-00164288102019-11-033f01610625f2…
2019-12-14 00:12 UTC2019-12N021229-00164036162019-11-153f01610625f2…
2019-09-15 20:21 UTC2019-09N021229-00164288102019-11-03b00525d2431f…
2019-09-15 20:21 UTC2019-09N021229-00164036162019-11-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N021229-00164288102019-11-03ea99ee380514…
2019-07-19 19:46 UTC2019-07N021229-00164036162019-11-15ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
426QFE7XLKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
402014Internal RxNorm lookup
608796Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
35a79458-79f6-44d6-b74c-b4f4aaf0dde0Available on FDA.report

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#

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37000-459-01370000459011 TABLET, DELAYED RELEASE in 1 POUCH (37000-459-01) 2012-08-150000-00-00NoNoCurrent