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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022032-001OMEPRAZOLEOMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022032-001125995652030-01-31Drug product2026-05-11

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate omeprazoleOMEPRAZOLEWal-Mart Stores Inc504b8282-d93f-454f-9f93-84cb8a9105d72025-03-25WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Allergy alert: • do not use if you are allergic to omeprazole. • omeprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you have: • trouble or pain swallowing food, vomiting with blood, or bloody or black stools • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have: • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if: • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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