FDA.reportPublic FDA data

Omeprazole

Product NDC
0781-2234
11-digit product format
007812234
Labeler code
0781
Product ID
0781-2234_fe6aa833-89e6-4679-a7b8-6600e92c1bed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA076515
Marketing category
ANDA
Marketing start
2009-01-21
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 1.

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
A076515-001OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076515-001AB

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 22:54:322026-06A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076515-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLESandoz Inc5a09ce48-7139-4fc7-9b6e-439459c8e8662024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076515
application number: ANDA076515
ndc (product): 0781-2234

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
5a09ce48-7139-4fc7-9b6e-439459c8e866Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-2234-012020-03-09C16284748780-19d75b9cf-e4c2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
0781-2234-102020-03-09C16284748780-19d75b9cf-e4c2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
0781-2234-312020-03-09C16284748780-19d75b9cf-e4c2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
0781-2234-012020-01-31C16284748780-19d75b9cf-e4c2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
0781-2234-102020-01-31C16284748780-19d75b9cf-e4c2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
0781-2234-312020-01-31C16284748780-19d75b9cf-e4c2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-2234-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10026
0781-2234-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100026
0781-2234-31Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2234-01EA - Each0781-22345fba6c57-0204-49b9-a00d-f7db698ab0a712012-07-24
0781-2234-10EA - Each0781-223490e62746-3817-4eff-a436-f1a7755fa38512012-07-24
0781-2234-31EA - Each0781-223412e81638-2ed5-448b-af1b-e1755eaf1d0912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
ACETONEINACTIVE INGREDIENT1364PS73AFOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKROMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
POVIDONESINACTIVE INGREDIENTFZ989GH94EOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]14
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJOMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYOMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKROMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EOMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-2234OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]25Current NDC, Legacy NDC, 3 package rows20231020_5a09ce48-7139-4fc7-9b6e-439459c8e866.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN5a09ce48-7139-4fc7-9b6e-439459c8e86626
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD5a09ce48-7139-4fc7-9b6e-439459c8e86626
200329omeprazole 40 MG Delayed Release Oral CapsulePSN89691e50-c250-6c87-e053-2995a90a27052
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD89691e50-c250-6c87-e053-2995a90a27052

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-2234-0100781223401100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2234-01) 2009-01-210000-00-00NoNoCurrent
0781-2234-10007812234101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2234-10) 2009-01-210000-00-00NoNoCurrent
0781-2234-310078122343130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2234-31) 2009-01-210000-00-00NoNoCurrent