FDA.reportPublic FDA data

Omeprazole

Product NDC
68382-411
11-digit product format
683820411
Labeler code
68382
Product ID
68382-411_d0074baa-52cb-4039-9bd8-966a36ff70da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA091352
Marketing category
ANDA
Marketing start
2012-11-23
Substance
OMEPRAZOLE
Active strength
10 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
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
ndc (product): 68382-411

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE10 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198051Internal RxNorm lookup
199119Internal RxNorm lookup
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
9c22ceb2-2c34-43c3-9a35-2589c9078741Available 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
68382-411-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10018
68382-411-05Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50018
68382-411-06Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3018
68382-411-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100018
68382-411-16Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-411-01EA - Each68382-411042c3188-4a0e-4de0-b782-8f6f0d1a5b6512013-02-13
68382-411-06EA - Each68382-41174fbd8af-f698-4929-ad96-b41af26a414112013-02-13
68382-411-10EA - Each68382-41151bf1517-d466-40fa-b718-05ea9393d7f412013-02-13
68382-411-16EA - Each68382-411ab72ab10-44a6-4fc0-b85e-e4a46182643f12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
ACETONEINACTIVE INGREDIENT1364PS73AFOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671POMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)INACTIVE INGREDIENT8LDD2V82F5OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
SUCROSEINACTIVE INGREDIENTC151H8M554OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-411OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]18Current NDC, Legacy NDC, 5 package rows20230513_9c22ceb2-2c34-43c3-9a35-2589c9078741.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN9c22ceb2-2c34-43c3-9a35-2589c907874118
198051omeprazole 20 MG Delayed Release Oral CapsulePSN9c22ceb2-2c34-43c3-9a35-2589c907874118
200329omeprazole 40 MG Delayed Release Oral CapsulePSN9c22ceb2-2c34-43c3-9a35-2589c907874118
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD9c22ceb2-2c34-43c3-9a35-2589c907874118
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD9c22ceb2-2c34-43c3-9a35-2589c907874118
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD9c22ceb2-2c34-43c3-9a35-2589c907874118
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY9c22ceb2-2c34-43c3-9a35-2589c907874118
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY9c22ceb2-2c34-43c3-9a35-2589c907874118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-411-0168382041101100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-01) 2012-11-230000-00-00NoNoCurrent
68382-411-0568382041105500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-05) 2012-11-230000-00-00NoNoCurrent
68382-411-066838204110630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-06) 2012-11-230000-00-00NoNoCurrent
68382-411-10683820411101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-10) 2012-11-230000-00-00NoNoCurrent
68382-411-166838204111690 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-16) 2012-11-230000-00-00NoNoCurrent