Omeprazole

Product NDC
71335-9609
11-digit product format
713359609
Labeler code
71335
Product ID
71335-9609_d1a8c9e3-3ac2-476e-8a48-e117af47837d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075757
Marketing category
ANDA
Marketing start
2019-07-01
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075757-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28
A075757-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075757-001AB
A075757-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2003-01-28bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075757-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075757-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075757-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075757-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075757-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075757-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075757-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075757-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075757-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075757-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075757-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075757-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075757-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075757-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075757-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075757-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075757-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075757-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075757-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075757-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075757-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075757-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075757-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075757-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075757-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075757-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075757-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075757-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075757-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075757-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075757-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075757-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075757-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075757-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075757-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075757-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075757-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075757-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075757-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075757-002AB1bb7c543d1eb4…

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
17664f71-154a-47c6-b83c-b349bbc8a98fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9609-0Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE7104
71335-9609-1Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE30104
71335-9609-2Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE60104
71335-9609-3Omeprazole56 in 1 BOTTLECAPSULE, DELAYED RELEASE56104
71335-9609-4Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE90104
71335-9609-5Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE20104
71335-9609-6Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE15104
71335-9609-7Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE120104
71335-9609-8Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE100104
71335-9609-9Omeprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE28104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9609-1EA - Each71335-960909f8e273-b14d-4f47-ad0a-106fe8e2536712023-08-08
71335-9609-2EA - Each71335-96097dde5f6e-b577-4ecd-9b8b-f715c242039412023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9609OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240809_17664f71-154a-47c6-b83c-b349bbc8a98f.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacydb9f071b-85f4-061f-e053-2995a90a3ff52026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLEQPharma Incf6f6ad19-ff6a-7cd3-e053-6294a90ae1bf2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLENorthwind Health Company, LLCf76c23d5-26b6-cfb2-e053-6294a90aea422026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.0fb314cb-6291-422c-98ff-24d8449992f62025-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLEChartwell RX, LLC4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e2025-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLESandoz Inc516170d4-4913-4577-a2d2-f5c52d1e79c62024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLEProficient Rx LPee0598a1-0e5e-40ff-ad88-b0adfc533ca02024-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLEBryant Ranch Prepack17664f71-154a-47c6-b83c-b349bbc8a98f2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
ndc (product): 71335-9609
OmeprazoleOMEPRAZOLESandoz Ince4562da8-9d94-4417-9f80-c1ffd42472592023-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN17664f71-154a-47c6-b83c-b349bbc8a98f104
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD17664f71-154a-47c6-b83c-b349bbc8a98f104
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY17664f71-154a-47c6-b83c-b349bbc8a98f104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-9609-0713359609007 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-0) 2024-04-030000-00-00NoNoCurrent
71335-9609-17133596090130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-1) 2023-01-250000-00-00NoNoCurrent
71335-9609-27133596090260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-2) 2022-12-290000-00-00NoNoCurrent
71335-9609-37133596090356 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-3) 2024-04-030000-00-00NoNoCurrent
71335-9609-47133596090490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-4) 2023-02-140000-00-00NoNoCurrent
71335-9609-57133596090520 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-5) 2024-04-030000-00-00NoNoCurrent
71335-9609-67133596090615 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-6) 2023-04-280000-00-00NoNoCurrent
71335-9609-771335960907120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-7) 2022-12-150000-00-00NoNoCurrent
71335-9609-871335960908100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-8) 2024-04-030000-00-00NoNoCurrent
71335-9609-97133596090928 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9609-9) 2024-04-030000-00-00NoNoCurrent