equate omeprazole

Product NDC
49035-119
11-digit product format
490350119
Labeler code
49035
Product ID
49035-119_65ea67fd-2018-49ce-bccf-3d4ccf4f235b
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
NDA022032
Marketing category
NDA
Marketing start
2015-09-02
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

Additional Listing Data#

Finished product
Yes
Brand name base
equate omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui402014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-119-01equate omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE146
49035-119-01equate omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE16
49035-119-03equate omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE36
49035-119-03equate omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE146

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-119-01EA - Each49035-11936c0bab8-4475-4638-b61e-f943cffcfa5612019-12-10
49035-119-03EA - Each49035-119261dc85f-1e9b-4532-ab97-4ab85b9d70a712024-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHEQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZEQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AEQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTEQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PEQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGEQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIEQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMEQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-119EQUATE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]6Current NDC, Legacy NDC, 4 package rows20250327_504b8282-d93f-454f-9f93-84cb8a9105d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN504b8282-d93f-454f-9f93-84cb8a9105d76
402014omeprazole 20 MG Delayed Release Oral TabletSCD504b8282-d93f-454f-9f93-84cb8a9105d76
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY504b8282-d93f-454f-9f93-84cb8a9105d76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-119-01490350119011 BOTTLE in 1 CARTON (49035-119-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2015-09-020000-00-00NoNoCurrent
49035-119-03490350119033 BOTTLE in 1 CARTON (49035-119-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2015-09-020000-00-00NoNoCurrent