Omeprazole

Product NDC
51655-452
Requested package NDC
51655-452-26
11-digit product format
516550452
Labeler code
51655
Product ID
51655-452_4b44baf6-9a17-c928-e063-6294a90a884e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA203270
Marketing category
ANDA
Marketing start
2022-09-26
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
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203270-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19
A203270-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19
A203270-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203270-001AB
A203270-002AB
A203270-003AB

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 22:38:342026-08A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-1984e616aacf4f…
2026-09-14 22:38:342026-08A203270-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-1984e616aacf4f…
2026-09-14 22:38:342026-08A203270-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-1984e616aacf4f…
2026-08-18 06:07:402026-07A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07A203270-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07A203270-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203270-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203270-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203270-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203270-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203270-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203270-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203270-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203270-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203270-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203270-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203270-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203270-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203270-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203270-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203270-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203270-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203270-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203270-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A203270-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A203270-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203270-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203270-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203270-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2015-08-19301d65b070ca…

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 22:38:342026-08A203270-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203270-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203270-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A203270-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203270-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203270-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203270-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203270-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203270-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203270-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203270-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203270-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203270-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203270-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203270-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203270-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203270-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203270-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203270-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203270-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203270-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203270-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203270-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203270-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203270-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203270-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203270-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203270-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203270-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203270-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203270-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203270-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203270-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203270-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203270-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203270-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203270-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203270-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203270-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203270-001AB1301d65b070ca…

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
2027-12-31

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
f3038133-8bb2-044e-e053-2995a90a6e7dAvailable 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
51655-452-25Omeprazole60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE604
51655-452-26Omeprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-452OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240723_f3038133-8bb2-044e-e053-2995a90a6e7d.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEQPharma Inc50115204-74f7-17c1-e063-6394a90ab6652026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLEPreferred Phharmaceuticals Inc.319d990e-161b-4c16-b026-f55c413c7e8f2026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLEProficient Rx LP61eab342-61fd-471f-8f70-95f9cbca00972026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLEA-S Medication Solutionsc1276463-7357-45b5-9f7e-8d3c4a550ff42026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLEA-S Medication Solutionsdf1a4294-3893-4a11-b4d5-f3536678087e2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.af707c0a-5193-3f83-e053-2995a90a78ef2026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLENorthwind Health Company, LLC10a3fbc9-00c6-ad83-e063-6294a90ae1ad2026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLENorthwind Health Company, LLCf3038133-8bb2-044e-e053-2995a90a6e7d2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
ndc (package): 51655-452-26
ndc (product): 51655-452
ndc11 (package): 51655045226
OmeprazoleOMEPRAZOLEQPharma, Inc.f5dd5d63-1376-1ff7-e053-2a95a90a1d942025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLEBryant Ranch Prepack40b4e1b6-f64d-44d5-bfc2-0cb8f78d9e672025-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLEBryant Ranch Prepack064b1418-0f42-4b18-9dee-cda40c5e1fca2024-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLEBryant Ranch Prepackc311c1b9-8ec2-4ac0-baa2-a5063fba2d802024-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLERising Pharma Holdings, Inc.a1b1c61b-d4fe-433d-ad31-0b11758976fa2024-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLEA-S Medication Solutionsfe7d3352-d53f-4046-92ed-1eb5c917fbee2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLEA-S Medication Solutions8d925ca6-83f1-4263-8218-4bf7cc8ceb392024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLEA-S Medication Solutions9378c870-f2cc-4a60-b0fd-08a4d43857bc2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270
OmeprazoleOMEPRAZOLEAurobindo Pharma Limited934601b6-fbba-43c4-a8ef-7a7dfe9f9a512024-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203270
application number: ANDA203270

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNf3038133-8bb2-044e-e053-2995a90a6e7d4
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDf3038133-8bb2-044e-e053-2995a90a6e7d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-452-265165504522690 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-452-26) 2022-09-26NoNoCurrent