FDA.reportPublic FDA data

Omeprazole 20 mg

Product NDC
25000-091
11-digit product format
250000091
Labeler code
25000
Product ID
25000-091_dcf79426-6aec-432a-aabe-dcb98c0f2cec
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole 20 mg
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA218829
Marketing category
ANDA
Marketing start
2025-08-12
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 42.

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
A218829-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-07

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-0731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-07a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole 20 mg
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
402014Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
921bf750-9dd7-42ff-82bb-043b03f0fe69Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25000-091-76Omeprazole 20 mg1 in 1 CARTONTABLET, DELAYED RELEASE13
25000-091-76Omeprazole 20 mg14 in 1 BOTTLETABLET, DELAYED RELEASE143
25000-091-77Omeprazole 20 mg7 in 1 BLISTER PACKTABLET, DELAYED RELEASE73
25000-091-77Omeprazole 20 mg2 in 1 CARTONTABLET, DELAYED RELEASE23

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole 20 mgOMEPRAZOLE 20 MGMARKSANS PHARMA LIMITED5baf6e08-8a5a-4ec0-af6d-eb73c6487e0c2026-08-05WarningsExact identifier
application applno (ANDA): 218829
application number: ANDA218829
Omeprazole Delayed-ReleaseOMEPRAZOLEH-E-B448ba584-6a6e-3d85-e063-6294a90a55792026-04-29WarningsExact identifier
application applno (ANDA): 218829
application number: ANDA218829
24 HOUR OmeprazoleOMEPRAZOLE 20 MGGrocery Outlet, Inc.4466f17c-c27b-8393-e063-6394a90a803d2026-03-23WarningsExact identifier
application applno (ANDA): 218829
application number: ANDA218829
Omeprazole delayed releaseOMEPRAZOLE 20MGTIME CAP LABORATORIES, INC.40906798-cd84-fbd0-e063-6294a90a1d292025-11-22WarningsExact identifier
application applno (ANDA): 218829
application number: ANDA218829
Omeprazole 20 mgOMEPRAZOLE 20 MGMARKSANS PHARMA LIMITED921bf750-9dd7-42ff-82bb-043b03f0fe692025-08-11WarningsExact identifier
application applno (ANDA): 218829
application number: ANDA218829
ndc (product): 25000-091

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN921bf750-9dd7-42ff-82bb-043b03f0fe693
402014omeprazole 20 MG Delayed Release Oral TabletSCD921bf750-9dd7-42ff-82bb-043b03f0fe693
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY921bf750-9dd7-42ff-82bb-043b03f0fe693

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25000-091-76250000091761 BOTTLE in 1 CARTON (25000-091-76) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2025-08-12NoNoCurrent
25000-091-77250000091772 BLISTER PACK in 1 CARTON (25000-091-77) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2025-08-12NoNoCurrent