FDA.reportPublic FDA data

Omeprazole

Product NDC
16714-630
11-digit product format
167140630
Labeler code
16714
Product ID
16714-630_fe36a9a7-13d0-f4f1-1e31-b35cf651b79d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA078490
Marketing category
ANDA
Marketing start
2026-03-01
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
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078490-001OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-04-17
A078490-002OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-03-16
A078490-003OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078490-001AB
A078490-002AB
A078490-003AB

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 22:54:322026-06A078490-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-04-17a50c72e98297…
2026-08-01 22:54:322026-06A078490-002OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-03-16a50c72e98297…
2026-08-01 22:54:322026-06A078490-003OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-03-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078490-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078490-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078490-003AB1a50c72e98297…

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.0344268f-d8e6-48d5-b1e1-f750ed1d8a522026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacy4c0cf466-f9e8-390e-e063-6294a90a2ed82026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.96104ea6-c08f-40b5-83f5-d840b317f1fd2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.e07af8c9-559c-5a93-e053-2a95a90a2c632026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLEDr. Reddy's Laboratories Limited603d2d06-c5e8-4378-a422-8dca1a410af72026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLENorthStar Rx LLC40a75dc7-49b7-5c9d-6c5f-d4682ec6922e2026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
ndc (product): 16714-630
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.63b3982a-b541-4b0d-99d4-93a673e57d462026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.288bdd5e-a0ac-4c5c-abe0-93183a28dcdd2026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLENorthwind Health Company, LLC4720cc17-013e-074e-e063-6294a90ac1f42025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLERedpharm Drug2fd1acb8-12dc-70b7-e063-6394a90a03992025-12-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLEAmerican Health Packaging205652e1-7fbc-4b6a-bbd6-2fd346d812df2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals, Inc.28515ff8-379d-5356-e063-6394a90af3f32025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC3724b8f7-52ff-a5f8-e063-6294a90acf202025-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLEQuallent Pharmaceuticals Health LLC8090d4c3-3184-7812-53d7-aa30e14b79d12025-08-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLEPHOENIX RX LLC3b19d724-821b-61dc-e063-6294a90aa4d32025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLEAdvanced Rx of Tennessee, LLC30955530-56d2-174d-e063-6294a90a413c2025-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC40f66cac-bc23-43f9-9966-87cce458c9962025-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC2dcd48e4-9ffc-9cc2-e063-6294a90ae17e2025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLECoupler LLC2cdc6809-3b1b-046a-e063-6394a90ae02a2025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.a806da8c-5f84-454d-966c-da1c48710f802025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078490
application number: ANDA078490

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2027-12-31

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
40a75dc7-49b7-5c9d-6c5f-d4682ec6922eAvailable 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
16714-630-01Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-630-01EA - Each16714-6306081b009-82ab-49d4-9c42-d2b725a7073c12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
198051omeprazole 20 MG Delayed Release Oral CapsulePSN40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
200329omeprazole 40 MG Delayed Release Oral CapsulePSN40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
16714-630-011671406300130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-630-01) 2026-03-01NoNoCurrent