Omeprazole

Product NDC
60505-0146
11-digit product format
605050146
Labeler code
60505
Product ID
60505-0146_8619e520-d106-4778-e92a-09b919b55c70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Apotex Corp
Application
ANDA076048
Marketing category
ANDA
Marketing start
2009-01-21
Marketing end
2027-01-31
Substance
OMEPRAZOLE
Active strength
40 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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-014660505-0146-0DDiscontinued by firm2026-08-17
excluded packagepackage60505-014660505-0146-9DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076048-001OMEPRAZOLE10MGCAPSULE, 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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-221e350fbaab3a…

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 06:07:402026-07A076048-001AB1caaa826d4ba7…
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076048-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE40 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
b83329ac-a65e-b3af-a3fb-c5a6c740e5e7Available 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
60505-0146-0Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3035
60505-0146-1Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50035
60505-0146-2Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10035
60505-0146-9Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0146-0EA - Each60505-014633b75d5f-a580-47ce-83f9-2f43593d28af12012-07-24
60505-0146-1EA - Each60505-0146140ecd10-0a3c-490d-80fd-8de6b9a8648912012-07-24
60505-0146-2EA - Each60505-014670ea9f18-24b9-4279-83bf-8bf5f46d976612012-07-24
60505-0146-9EA - Each60505-0146048b48cd-bc16-4e15-9114-e3520224eb0b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OmeprazoleACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
OmeprazoleACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
OmeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
OmeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]15
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
OmeprazoleACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
OmeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
OmeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
OmeprazoleACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]1
OmeprazoleACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
OmeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]1
OmeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0146OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]35Current NDC, Legacy NDC, 4 package rows20240423_b83329ac-a65e-b3af-a3fb-c5a6c740e5e7.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
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
ndc (product): 60505-0146
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
199119omeprazole 10 MG Delayed Release Oral CapsulePSNb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
198051omeprazole 20 MG Delayed Release Oral CapsulePSNb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
200329omeprazole 40 MG Delayed Release Oral CapsulePSNb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
199119omeprazole 10 MG Delayed Release Oral CapsuleSCDb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSYb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
200329omeprazole 40 MG Delayed Release Oral CapsulePSN03367fd2-bf06-47f7-8a69-8f90a0b8173415
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD03367fd2-bf06-47f7-8a69-8f90a0b8173415
198051omeprazole 20 MG Delayed Release Oral CapsulePSNc6bc8fb7-2862-464a-b7c9-e409034f072a14
200329omeprazole 40 MG Delayed Release Oral CapsulePSNc6bc8fb7-2862-464a-b7c9-e409034f072a14
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDc6bc8fb7-2862-464a-b7c9-e409034f072a14
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDc6bc8fb7-2862-464a-b7c9-e409034f072a14
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYc6bc8fb7-2862-464a-b7c9-e409034f072a14
200329omeprazole 40 MG Delayed Release Oral CapsulePSN253451a6-02a9-4b27-aed7-f3dbc2e096826
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD253451a6-02a9-4b27-aed7-f3dbc2e096826
198051omeprazole 20 MG Delayed Release Oral CapsulePSN44349466-73ea-4053-8ff6-5b4b7372c9cd5
200329omeprazole 40 MG Delayed Release Oral CapsulePSN44349466-73ea-4053-8ff6-5b4b7372c9cd5
200329omeprazole 40 MG Delayed Release Oral CapsulePSNb6e75ecc-4332-4bfc-8a77-4721178ebcca5
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD44349466-73ea-4053-8ff6-5b4b7372c9cd5
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD44349466-73ea-4053-8ff6-5b4b7372c9cd5
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDb6e75ecc-4332-4bfc-8a77-4721178ebcca5
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY44349466-73ea-4053-8ff6-5b4b7372c9cd5
198051omeprazole 20 MG Delayed Release Oral CapsulePSN0f560bc9-9f40-0f96-e054-00144ff88e884
200329omeprazole 40 MG Delayed Release Oral CapsulePSN0f560bc9-9f40-0f96-e054-00144ff88e884
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD0f560bc9-9f40-0f96-e054-00144ff88e884
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD0f560bc9-9f40-0f96-e054-00144ff88e884
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY0f560bc9-9f40-0f96-e054-00144ff88e884
200329omeprazole 40 MG Delayed Release Oral CapsulePSNa0dc4ffa-db18-4871-9d36-51d02e3b2bd91
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDa0dc4ffa-db18-4871-9d36-51d02e3b2bd91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0146-06050501460030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-0) 2009-01-210000-00-00NoNoCurrent
60505-0146-160505014601500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-1) 2009-01-212027-01-31NoNoCurrent
60505-0146-260505014602100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-2) 2009-01-212027-01-31NoNoCurrent
60505-0146-96050501460990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-9) 2009-01-210000-00-00NoNoCurrent