FDA.reportPublic FDA data

Omeprazole Delayed-Release

Product NDC
37808-569
11-digit product format
378080569
Labeler code
37808
Product ID
37808-569_50962214-2053-1974-e063-6394a90a0fc0
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
H-E-B
Application
ANDA218829
Marketing category
ANDA
Marketing start
2026-07-01
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
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
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
2026-09-14 22:38:342026-08A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-0784e616aacf4f…
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…

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
Omeprazole Delayed-Release
Listing expiration
2027-12-31

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
448ba584-6a6e-3d85-e063-6294a90a5579Available on FDA.report

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
ndc (product): 37808-569
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37808-569-41378080569413 BOTTLE in 1 CARTON (37808-569-41) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2026-07-01NoNoCurrent
37808-569-45378080569451 BOTTLE in 1 CARTON (37808-569-45) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2026-07-01NoNoCurrent
37808-569-82378080569822 BOTTLE in 1 CARTON (37808-569-82) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2026-07-01NoNoCurrent