Omeprazole

Product NDC
71335-1636
11-digit product format
713351636
Labeler code
71335
Product ID
71335-1636_edbe8fe0-7fe4-4a6a-b857-622b98fc85a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076048
Marketing category
ANDA
Marketing start
2003-11-11
Marketing end
2027-01-31
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
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076048-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22
A076048-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22
A076048-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076048-001AB
A076048-002AB
A076048-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2284e616aacf4f…
2026-09-14 22:38:342026-08A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2284e616aacf4f…
2026-09-14 22:38:342026-08A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2184e616aacf4f…
2026-08-18 06:07:402026-07A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076048-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076048-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076048-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A076048-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076048-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076048-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076048-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076048-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076048-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076048-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076048-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076048-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076048-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076048-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076048-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole

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
1249c42d-6358-48b3-8fe0-10333c7f501dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1636-0Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE72
71335-1636-1Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
71335-1636-2Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
71335-1636-3Omeprazole56 in 1 BOTTLECAPSULE, DELAYED RELEASE562
71335-1636-4Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE902
71335-1636-5Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE202
71335-1636-6Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE152
71335-1636-7Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1202
71335-1636-8Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1002
71335-1636-9Omeprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1636OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]2Current NDC, Legacy NDC, 10 package rows20241121_1249c42d-6358-48b3-8fe0-10333c7f501d.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEBryant Ranch Prepack1249c42d-6358-48b3-8fe0-10333c7f501d2024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
ndc (product): 71335-1636
OmeprazoleOMEPRAZOLEBryant Ranch Prepack44349466-73ea-4053-8ff6-5b4b7372c9cd2024-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
OmeprazoleOMEPRAZOLEProficient Rx LP03ac077f-3873-4087-96d0-89049161dea92024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
OmeprazoleOMEPRAZOLEProficient Rx LP253451a6-02a9-4b27-aed7-f3dbc2e096822024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
OmeprazoleOMEPRAZOLEApotex Corpb83329ac-a65e-b3af-a3fb-c5a6c740e5e72024-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCa0dc4ffa-db18-4871-9d36-51d02e3b2bd92019-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN1249c42d-6358-48b3-8fe0-10333c7f501d2
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD1249c42d-6358-48b3-8fe0-10333c7f501d2
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY1249c42d-6358-48b3-8fe0-10333c7f501d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1636-0713351636007 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-0) 2024-10-312027-01-31NoNoCurrent
71335-1636-17133516360130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-1) 2024-10-312027-01-31NoNoCurrent
71335-1636-27133516360260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-2) 2024-10-312027-01-31NoNoCurrent
71335-1636-37133516360356 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-3) 2024-10-312027-01-31NoNoCurrent
71335-1636-47133516360490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-4) 2024-10-312027-01-31NoNoCurrent
71335-1636-57133516360520 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-5) 2024-10-312027-01-31NoNoCurrent
71335-1636-67133516360615 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-6) 2024-10-312027-01-31NoNoCurrent
71335-1636-771335163607120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-7) 2024-10-312027-01-31NoNoCurrent
71335-1636-871335163608100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-8) 2024-10-312027-01-31NoNoCurrent
71335-1636-97133516360928 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-9) 2024-10-312027-01-31NoNoCurrent