FDA.reportPublic FDA data

Omeprazole

Product NDC
71610-663
11-digit product format
716100663
Labeler code
71610
Product ID
71610-663_31e57817-b8c3-8178-e063-6294a90a0149
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA212977
Marketing category
ANDA
Marketing start
2020-12-10
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
A212977-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-12-10
A212977-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-12-10
A212977-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2024-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212977-001AB
A212977-002AB
A212977-003AB

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 22:54:322026-06A212977-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-12-10a50c72e98297…
2026-08-01 22:54:322026-06A212977-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-12-10a50c72e98297…
2026-08-01 22:54:322026-06A212977-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2024-12-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212977-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A212977-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A212977-003AB1a50c72e98297…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.ded0df8b-1813-4595-ac2b-5499704bfd482026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC43090803-37de-77e3-e063-6294a90a8c432025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEA-S Medication Solutions6ea9a6f3-b756-4cdf-b3db-f666a2c17d662025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEA-S Medication Solutions530a8a66-48ad-474f-b170-c6fac95753ec2025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEGolden State Medical Supply, Inc.ded71262-d17f-3799-e053-2995a90a54272025-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEGolden State Medical Supply, Inc.f873dc20-c817-5e4f-e053-6394a90a04f22025-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCe87d2206-9c06-438c-947b-10b29a879d7b2025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
ndc (product): 71610-663
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC2e5d1b21-6b32-0c8d-e063-6294a90a84312025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLENCS HealthCare of KY, LLC dba Vangard Labsf226173f-4318-43e0-847a-8ea237e6b41d2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEBoswell Pharmacy Services LLC d/b/a BPS Wholesale1ab3d84c-c563-6f04-e063-6394a90a34ff2024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEProficient Rx LP13b379ef-7982-434d-9e6b-e01cd2b398d22023-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEProficient Rx LP2fc5065c-5850-469b-b357-fa4df30a8f782022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEXiromed, LLC38bd8e13-591e-f11b-7d8a-11717c56493c2022-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977

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
e87d2206-9c06-438c-947b-10b29a879d7bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-663-00Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10008
71610-663-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE308
71610-663-51Omeprazole4800 in 1 BOTTLECAPSULE, DELAYED RELEASE48008
71610-663-53Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE608
71610-663-56Omeprazole9200 in 1 BOTTLECAPSULE, DELAYED RELEASE92008
71610-663-60Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE908
71610-663-70Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1208
71610-663-80Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1808
71610-663-87Omeprazole2400 in 1 BOTTLECAPSULE, DELAYED RELEASE24008
71610-663-94Omeprazole360 in 1 BOTTLECAPSULE, DELAYED RELEASE3608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-663-30EA - Each71610-663cc38c5b7-fe81-4def-afb3-ea5d35a32f8d12022-11-07
71610-663-51EA - Each71610-6635e3f5b6f-38fd-4494-ab1d-d24eed9355fb12024-08-12
71610-663-53EA - Each71610-6632effd053-0d72-4b61-8b41-279651a250bd12022-11-07
71610-663-56EA - Each71610-6634d6a60d0-6547-456d-b286-50e981c2543212024-08-12
71610-663-60EA - Each71610-663000904bc-7c08-4b31-98b6-7d6374eea34612022-11-07
71610-663-70EA - Each71610-6631cd03ae8-51b9-4b67-a3ee-d7eb27565c4d12023-12-05
71610-663-80EA - Each71610-66311f8b22b-8014-4917-bcfb-a818b67326aa12023-12-05
71610-663-87EA - Each71610-66386fafd38-171b-414f-951c-f9a31d8f80e112024-08-12
71610-663-94EA - Each71610-663b6617522-fe10-49d9-82b9-9899bef9dd4812022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-663OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]8Current NDC, Legacy NDC, 10 package rows20250406_e87d2206-9c06-438c-947b-10b29a879d7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNe87d2206-9c06-438c-947b-10b29a879d7b8
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDe87d2206-9c06-438c-947b-10b29a879d7b8
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYe87d2206-9c06-438c-947b-10b29a879d7b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-663-00716100663001000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-00) 2025-04-01NoNoCurrent
71610-663-307161006633030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-30) 2022-09-080000-00-00NoNoCurrent
71610-663-51716100663514800 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-51) 2024-06-06NoNoCurrent
71610-663-537161006635360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-53) 2022-09-080000-00-00NoNoCurrent
71610-663-56716100663569200 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-56) 2024-06-06NoNoCurrent
71610-663-607161006636090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-60) 2022-09-080000-00-00NoNoCurrent
71610-663-7071610066370120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-70) 2022-11-150000-00-00NoNoCurrent
71610-663-8071610066380180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-80) 2022-11-21NoNoCurrent
71610-663-87716100663872400 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-87) 2024-06-06NoNoCurrent
71610-663-9471610066394360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-663-94) 2022-09-190000-00-00NoNoCurrent