FDA.reportPublic FDA data

Omeprazole

Product NDC
16714-715
11-digit product format
167140715
Labeler code
16714
Product ID
16714-715_3003d0a8-047d-133a-00cf-a3db676666f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA075576
Marketing category
ANDA
Marketing start
2019-10-25
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16714-715DDiscontinued by firm2026-07-31
excluded packagepackage16714-71516714-715-01DDiscontinued by firm2026-07-31
excluded packagepackage16714-71516714-715-02DDiscontinued by firm2026-07-31
excluded packagepackage16714-71516714-715-03DDiscontinued by firm2026-07-31

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
A075576-001OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21
A075576-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22
A075576-003OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075576-001AB
A075576-002AB
A075576-003AB

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 22:54:322026-06A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21a50c72e98297…
2026-08-01 22:54:322026-06A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22a50c72e98297…
2026-08-01 22:54:322026-06A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075576-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075576-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075576-003AB1a50c72e98297…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacy1eb57c13-25ed-70bc-e063-6294a90afdac2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLENorthwind Health Company, LLCaae3bf9f-5d05-889f-e053-2995a90a5ff22025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEQPharma, Inc.f5dcf0b2-4fa2-023a-e053-2995a90a183a2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEQuallent Pharmaceuticals Health LLC665e9877-85ac-fdb6-54ac-1c47941ceab82025-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.e235ef89-3592-4ca1-8c13-d7ce84b1001c2025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEAmerican Health Packaginga17e415e-a559-4a8d-a455-699184a015232025-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
Omeprazole DROMEPRAZOLEAdvanced Rx of Tennessee, LLCaf85e324-ef9f-196c-e053-2995a90a384e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEQuality Care Products, LLC581d1c3d-457a-41f2-8db0-5b6219cdcb092024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEProficient Rx LPf0f61a89-700d-481d-9255-6f9a9afa70252024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEAdvanced Rx of Tennessee, LLC1d4ecc1e-5180-f75e-e063-6394a90a51a62024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEBryant Ranch Prepacke1f20429-cfaa-420b-a65a-271be37eb7992024-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEDr. Reddy's Laboratories Limited72fb11b6-b08c-2f02-d82b-f60f523949032024-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEA-S Medication Solutionsb129fe93-c8a2-4ae8-ad1b-8f9ae5779b682023-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLENorthStar Rx LLCc5af5f4b-17be-7245-b281-f27c878312422023-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
ndc (product): 16714-715

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
16714-715-01Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
16714-715-02Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1006
16714-715-03Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-715-01EA - Each16714-715aed37835-60a0-4c5f-a7c8-e60907ef6f6112020-02-13
16714-715-02EA - Each16714-715d9b1a74f-a0d5-4251-9ed3-0fe22329884a12020-02-13
16714-715-03EA - Each16714-715e46ec2ef-a71c-4676-b0c3-6bc079609e6612020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-715OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHSTAR RX LLC]6Current NDC, Legacy NDC, 3 package rows20231227_c5af5f4b-17be-7245-b281-f27c87831242.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNaf85e324-ef9f-196c-e053-2995a90a384e9
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDaf85e324-ef9f-196c-e053-2995a90a384e9
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYaf85e324-ef9f-196c-e053-2995a90a384e9
199119omeprazole 10 MG Delayed Release Oral CapsulePSNc5af5f4b-17be-7245-b281-f27c878312426
198051omeprazole 20 MG Delayed Release Oral CapsulePSNc5af5f4b-17be-7245-b281-f27c878312426
199119omeprazole 10 MG Delayed Release Oral CapsuleSCDc5af5f4b-17be-7245-b281-f27c878312426
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDc5af5f4b-17be-7245-b281-f27c878312426
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSYc5af5f4b-17be-7245-b281-f27c878312426
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYc5af5f4b-17be-7245-b281-f27c878312426
198051omeprazole 20 MG Delayed Release Oral CapsulePSNbc1d591a-3835-e251-e053-2a95a90aab891
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDbc1d591a-3835-e251-e053-2a95a90aab891
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYbc1d591a-3835-e251-e053-2a95a90aab891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-715-011671407150130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-715-01) 2019-10-250000-00-00NoNoCurrent
16714-715-0216714071502100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-715-02) 2019-10-250000-00-00NoNoCurrent
16714-715-03167140715031000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-715-03) 2019-10-250000-00-00NoNoCurrent