FDA.reportPublic FDA data

Equate omeprazole delayed release

Product NDC
49035-915
11-digit product format
490350915
Labeler code
49035
Product ID
49035-915_03d865a0-ac92-49d5-82e2-2276292add17
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
2008-02-27
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 delayed release
Brand name suffix
acid reducer
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
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
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-915-01Equate omeprazole delayed releaseacid reducer14 in 1 BOTTLETABLET, DELAYED RELEASE147
49035-915-01Equate omeprazole delayed releaseacid reducer1 in 1 CARTONTABLET, DELAYED RELEASE17
49035-915-03Equate omeprazole delayed releaseacid reducer3 in 1 CARTONTABLET, DELAYED RELEASE37
49035-915-03Equate omeprazole delayed releaseacid reducer14 in 1 BOTTLETABLET, DELAYED RELEASE147
49035-915-30Equate omeprazole delayed releaseacid reducer2 in 1 CARTONTABLET, DELAYED RELEASE27
49035-915-30Equate omeprazole delayed releaseacid reducer14 in 1 CARTONTABLET, DELAYED RELEASE147
49035-915-55Equate omeprazole delayed releaseacid reducer14 in 1 CARTONTABLET, DELAYED RELEASE147
49035-915-55Equate omeprazole delayed releaseacid reducer3 in 1 CARTONTABLET, DELAYED RELEASE37
49035-915-74Equate omeprazole delayed releaseacid reducer14 in 1 CARTONTABLET, DELAYED RELEASE147
49035-915-74Equate omeprazole delayed releaseacid reducer1 in 1 BLISTER PACKTABLET, DELAYED RELEASE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-915-01EA - Each49035-9156840ceba-17b5-488a-b1c8-f8cbee3f173512019-07-02
49035-915-03EA - Each49035-9156fd0b099-8e93-4931-b37d-d3977cefe95512022-06-06
49035-915-30EA - Each49035-915bd23f00d-ccf4-4744-8648-d7be8c71d7ce12012-07-24
49035-915-55EA - Each49035-9156dad407b-c126-40fe-92a3-57566ec8a50312012-07-24
49035-915-74EA - Each49035-9150a79ad4b-b87c-438e-ad37-9db25ce59d8b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9EQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
OMEPRAZOLEACTIVE MOIETYKG60484QX9EQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZEQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTEQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGEQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIEQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMEQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-915EQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC]7Current NDC, Legacy NDC, 10 package rows20241209_9a0f2d8a-eaad-403b-90c3-0fd275abe4dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN9a0f2d8a-eaad-403b-90c3-0fd275abe4dc7
402014omeprazole 20 MG Delayed Release Oral TabletSCD9a0f2d8a-eaad-403b-90c3-0fd275abe4dc7
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY9a0f2d8a-eaad-403b-90c3-0fd275abe4dc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-915-01490350915011 BOTTLE in 1 CARTON (49035-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2012-04-090000-00-00NoNoCurrent
49035-915-03490350915033 BOTTLE in 1 CARTON (49035-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2012-05-210000-00-00NoNoCurrent
49035-915-30490350915302 CARTON in 1 CARTON (49035-915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 carton2008-02-270000-00-00NoNoCurrent
49035-915-554903509155514 in 1 CARTONHistorical
49035-915-744903509157414 in 1 CARTONHistorical