Prilosec OTC

Product NDC
37000-459
Requested package NDC
37000-459-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-09-29 23:25 UTC2022-09N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20cb3db0bc1861…

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…

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prilosec OTCOMEPRAZOLE MAGNESIUMThe Procter & Gamble Manufacturing Company77ed80a2-a482-4838-ac55-4865b5c31d9f2025-10-01WarningsExact identifier
application applno (NDA): 021229
application number: NDA021229
Prilosec OTCOMEPRAZOLE MAGNESIUMThe Procter & Gamble Manufacturing Company35a79458-79f6-44d6-b74c-b4f4aaf0dde02025-10-01WarningsExact identifier
application applno (NDA): 021229
application number: NDA021229
ndc (package): 37000-459-01
ndc (product): 37000-459
ndc11 (package): 37000045901

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