FDA.reportPublic FDA data

OMESEC

Product NDC
16853-1308
11-digit product format
168531308
Labeler code
16853
Product ID
16853-1308_b16d55b9-70a2-4734-a8f4-bfd1cd108be4
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Corporacion Infarmasa
Application
ANDA075410
Marketing category
ANDA
Marketing start
2010-02-28
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16853-1308IInactivated by FDA2026-08-03
excluded packagepackage16853-130816853-1308-1IInactivated by FDA2026-08-03
excluded packagepackage16853-130816853-1308-2IInactivated by FDA2026-08-03
excluded packagepackage16853-130816853-1308-3IInactivated by FDA2026-08-03
excluded packagepackage16853-130816853-1308-4IInactivated by FDA2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075410-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01
A075410-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01
A075410-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075410-001AB
A075410-002AB
A075410-003AB

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
2026-08-01 22:54:322026-06A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01a50c72e98297…
2026-08-01 22:54:322026-06A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01a50c72e98297…
2026-08-01 22:54:322026-06A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075410-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075410-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075410-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEChartwell RX, LLC10f5502a-2e63-4f2a-a3ba-ddc5bd4030512025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.ed9895ae-3d18-434c-8b56-47bccdc8fe6d2025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.ad675ef6-5377-b9f2-e053-2995a90a06e92024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.55a1fb3c-f040-2e39-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.8991d464-7abc-4350-e053-2995a90a4ea72024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEBryant Ranch Prepack1318a1c1-222d-471a-92d6-3632c82fb9992024-05-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEBryant Ranch Prepack18f5a7cc-40d8-4aeb-a601-47bc9024f1302024-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLELannett Company, Inc.92201fb1-4570-42db-8da3-3b8c0e291d322023-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEProficient Rx LP9786b04f-f827-460b-91bc-c0ac967f95dd2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC4b188d97-f1b3-468d-9818-b8333bf24b5a2020-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16853-1308-12019-10-21C16284748780-1956f9ecf-c6b4-621f-e053-dbdaa90a74adDrug Facts
16853-1308-22019-10-21C16284748780-1956f9ecf-c6b4-621f-e053-dbdaa90a74adDrug Facts
16853-1308-32019-10-21C16284748780-1956f9ecf-c6b4-621f-e053-dbdaa90a74adDrug Facts
16853-1308-42019-10-21C16284748780-1956f9ecf-c6b4-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16853-1308-1OMESEC14 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE143
16853-1308-2OMESEC28 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE283
16853-1308-3OMESEC42 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE423
16853-1308-4OMESEC2 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE23

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA]3
OmeprazoleACTIVE MOIETYKG60484QX9OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA]3
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFOMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671POMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA]3
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOOMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA]3
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)INACTIVE INGREDIENT8LDD2V82F5OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GOMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA]3
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TOMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA]3
SUCROSEINACTIVE INGREDIENTC151H8M554OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16853-1308OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA]3Legacy NDC, 4 package rows20100603_9217efc8-ec38-45e1-8319-32a6303cc050.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN9217efc8-ec38-45e1-8319-32a6303cc0503
967525omeprazole 20 MG Delayed Release Oral Capsule [Omesec]SBD9217efc8-ec38-45e1-8319-32a6303cc0503
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD9217efc8-ec38-45e1-8319-32a6303cc0503
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY9217efc8-ec38-45e1-8319-32a6303cc0503
967525Omesec 20 MG Delayed Release Oral CapsuleSY9217efc8-ec38-45e1-8319-32a6303cc0503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
16853-1308-11685313080114 in 1 BLISTER PACKHistorical
16853-1308-21685313080228 in 1 BLISTER PACKHistorical
16853-1308-31685313080342 in 1 BLISTER PACKHistorical
16853-1308-4168531308042 in 1 BLISTER PACKHistorical