FDA.reportPublic FDA data

Omeprazole

Product NDC
0904-6917
11-digit product format
009046917
Labeler code
0904
Product ID
0904-6917_54091ab1-10e5-4a5c-8abc-e58d24d24168
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA091352
Marketing category
ANDA
Marketing start
2012-11-23
Substance
OMEPRAZOLE
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
2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091352-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-11-19
A091352-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-11-19
A091352-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-11-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091352-001AB
A091352-002AB
A091352-003AB

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 22:54:322026-06A091352-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-11-19a50c72e98297…
2026-08-01 22:54:322026-06A091352-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-11-19a50c72e98297…
2026-08-01 22:54:322026-06A091352-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-11-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091352-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091352-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A091352-003AB1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEMajor Pharmaceuticalsafda9d2c-b141-4c32-a5b4-e850974b30a32025-09-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352
ndc (product): 0904-6917
OmeprazoleOMEPRAZOLECardinal Health 107, LLCfbd71fd8-3f36-46a1-bc76-53f6820d42a22025-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352
OmeprazoleOMEPRAZOLEZydus Lifesciences Limited2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca22024-12-03Exact identifier
application applno (ANDA): 091352
application number: ANDA091352
OmeprazoleOMEPRAZOLEA-S Medication Solutions9724601b-bb12-4eb2-bc2e-0532976bf5d12024-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352
OmeprazoleOMEPRAZOLEA-S Medication Solutions0ef8d55f-6cae-4b58-844b-968d8e5b8c242024-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352
OmeprazoleOMEPRAZOLEA-S Medication Solutions1c99e189-93c0-4461-82c2-4521e6c4d5142024-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352
OmeprazoleOMEPRAZOLEBryant Ranch Prepack39e3b45a-8e9b-49d6-976a-6668f4e276492023-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352
OmeprazoleOMEPRAZOLEZydus Pharmaceuticals USA Inc.9c22ceb2-2c34-43c3-9a35-2589c90787412023-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 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
198051Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
afda9d2c-b141-4c32-a5b4-e850974b30a3Available 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
0904-6917-61Omeprazole100 in 1 CARTONCAPSULE, DELAYED RELEASE1006
0904-6917-61Omeprazole1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6917-61EA - Each0904-6917f96b5e26-c355-488a-a438-c947f45e8beb12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6917OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20240518_afda9d2c-b141-4c32-a5b4-e850974b30a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNfbd71fd8-3f36-46a1-bc76-53f6820d42a28
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDfbd71fd8-3f36-46a1-bc76-53f6820d42a28
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYfbd71fd8-3f36-46a1-bc76-53f6820d42a28
198051omeprazole 20 MG Delayed Release Oral CapsulePSNafda9d2c-b141-4c32-a5b4-e850974b30a36
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDafda9d2c-b141-4c32-a5b4-e850974b30a36
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYafda9d2c-b141-4c32-a5b4-e850974b30a36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6917-6100904691761100 BLISTER PACK in 1 CARTON (0904-6917-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK100 blister pack2012-11-230000-00-00NoNoCurrent