Omeprazole

Product NDC
71335-1532
11-digit product format
713351532
Labeler code
71335
Product ID
71335-1532_2d8d7573-8196-4fb8-bd73-351c763c5fd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075410
Marketing category
ANDA
Marketing start
2009-01-23
Substance
OMEPRAZOLE
Active strength
40 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 43.

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0184e616aacf4f…
2026-09-14 22:38:342026-08A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0184e616aacf4f…
2026-09-14 22:38:342026-08A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2384e616aacf4f…
2026-08-18 06:07:402026-07A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075410-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075410-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A075410-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A075410-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075410-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075410-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075410-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075410-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075410-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075410-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075410-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075410-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075410-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075410-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075410-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075410-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075410-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075410-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075410-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075410-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075410-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075410-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075410-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075410-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075410-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075410-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075410-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075410-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075410-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075410-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075410-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075410-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075410-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075410-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075410-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075410-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075410-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075410-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075410-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075410-001AB1301d65b070ca…

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KG60484QX9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200329Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1318a1c1-222d-471a-92d6-3632c82fb999Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1532-1Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE605
71335-1532-2Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
71335-1532-3Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE205
71335-1532-4Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE905
71335-1532-5Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
71335-1532-6Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1205
71335-1532-7Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1005
71335-1532-8Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1532-1EA - Each71335-1532ddfccac4-2a98-492a-a79d-8a52797ff4eb12022-09-12
71335-1532-2EA - Each71335-1532cca7401d-8fb9-4ca2-a390-13e1078e09ca12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1532OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 8 package rows20240526_1318a1c1-222d-471a-92d6-3632c82fb999.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 · 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
ndc (product): 71335-1532
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN1318a1c1-222d-471a-92d6-3632c82fb9995
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD1318a1c1-222d-471a-92d6-3632c82fb9995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1532-17133515320160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-1) 2020-03-130000-00-00NoNoCurrent
71335-1532-27133515320230 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-2) 2020-03-170000-00-00NoNoCurrent
71335-1532-37133515320320 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-3) 2022-03-100000-00-00NoNoCurrent
71335-1532-47133515320490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-4) 2020-04-240000-00-00NoNoCurrent
71335-1532-57133515320514 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-5) 2020-03-160000-00-00NoNoCurrent
71335-1532-671335153206120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-6) 2022-03-100000-00-00NoNoCurrent
71335-1532-771335153207100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-7) 2021-03-010000-00-00NoNoCurrent
71335-1532-871335153208180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1532-8) 2022-03-100000-00-00NoNoCurrent