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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16714-715DDiscontinued by firm2026-08-17
excluded packagepackage16714-71516714-715-01DDiscontinued by firm2026-08-17
excluded packagepackage16714-71516714-715-02DDiscontinued by firm2026-08-17
excluded packagepackage16714-71516714-715-03DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-211e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075576-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075576-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075576-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075576-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075576-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075576-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075576-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075576-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075576-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075576-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075576-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075576-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075576-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075576-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075576-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075576-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075576-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075576-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075576-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075576-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075576-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075576-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075576-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075576-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075576-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075576-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075576-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075576-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075576-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075576-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075576-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075576-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075576-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075576-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075576-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075576-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075576-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075576-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075576-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075576-001AB11e350fbaab3a…

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 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