Omeprazole Magnesium

Product NDC
0363-0042
11-digit product format
003630042
Labeler code
0363
Product ID
0363-0042_72501d02-0bb5-ea40-7dbc-35654a739c62
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Walgreens Company
Application
ANDA078878
Marketing category
ANDA
Marketing start
2015-09-01
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
A078878-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05

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 UTC2026-02A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053f01610625f2…
2019-09-15 20:21 UTC2019-09A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole Magnesium
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198051Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee8b1740-9bcf-5b70-bd8d-97f98303dc72Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0042-27EA - Each0363-004278d3c5c9-b01b-4ae6-b114-2ee74f0b852b12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLE MAGNESIUMACTIVE INGREDIENT426QFE7XLKOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
omeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
GelatinINACTIVE INGREDIENT2G86QN327LOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBUOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
Magnesium OxideINACTIVE INGREDIENT3A3U0GI71GOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
RAW SUGARINACTIVE INGREDIENT8M707QY5GHOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0042OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]9Current NDC, Legacy NDC20240816_ee8b1740-9bcf-5b70-bd8d-97f98303dc72.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMGericare Pharmaceuticals0e1f5d7c-5956-3be7-e054-00144ff8d46c2025-07-28WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMHEB5d8b3f5f-f680-64ae-b360-c0bd06b2ac922025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMCVS Health Corp.3bbfa87d-f8b7-19bd-9f12-39cba31ae0b32025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Marketing Associationab5d339b-2c02-611d-d5db-8e1891684fe02025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Acid ReducerOMEPRAZOLE MAGNESIUMLEADER/ Cardinal Health 110, Inc.1dc00f13-d1f5-15a0-32cc-4fc041865e722025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMAlbertsons Companies302b1332-181b-834b-4154-d849cb3a1ef02025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDiscount Drug Mart, Incdaeeba93-29d5-efb4-a591-3e72c4e503412025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUM 20.6MG CAPSULESThe Kroger Co.8a6bbc31-7c50-a730-4233-e346fd7eb5ba2025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inc.fe0eb905-2042-aed1-a67d-a219e76f679b2025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMWalgreens Companyee8b1740-9bcf-5b70-bd8d-97f98303dc722025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 0363-0042
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUM 20.6MG CAPSULESWal-Mart Stores Inc3160e212-9ee9-8316-f51e-4628862f654c2025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Consortium, LLC39ac65c0-d957-125f-f00b-e3846a4374892025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Marketing Associationfdf1259b-e9d3-70a9-c209-e2eb6b1528412025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Limited0e8fde83-a55c-edaf-3c66-e1fc77d0bc112025-05-28WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNee8b1740-9bcf-5b70-bd8d-97f98303dc7210
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDee8b1740-9bcf-5b70-bd8d-97f98303dc7210
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYee8b1740-9bcf-5b70-bd8d-97f98303dc7210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0042-01003630042013 BOTTLE in 1 CARTON (0363-0042-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2015-09-010000-00-00NoNoCurrent
0363-0042-27003630042272 BOTTLE in 1 CARTON (0363-0042-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2015-09-010000-00-00NoNoCurrent
0363-0042-33003630042333 BOTTLE in 1 CARTON (0363-0042-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2015-09-010000-00-00NoNoCurrent
0363-0042-52003630042521 BOTTLE in 1 CARTON (0363-0042-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2015-09-010000-00-00NoNoCurrent