Home NDC 49035-119 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022032-001 OMEPRAZOLE OMEPRAZOLE 20MG TABLET, DELAYED RELEASE / ORAL RLD, RS 2007-12-04
Orange Book patents# Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022032-001 12599565 2030-01-31 Drug product 2026-05-11
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.
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 Ingredient Strength OMEPRAZOLE 20 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii KG60484QX9 Rxcui 402014
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49035-119-01 equate omeprazole 14 in 1 BOTTLE TABLET, DELAYED RELEASE 14 6 49035-119-01 equate omeprazole 1 in 1 CARTON TABLET, DELAYED RELEASE 1 6 49035-119-03 equate omeprazole 3 in 1 CARTON TABLET, DELAYED RELEASE 3 6 49035-119-03 equate omeprazole 14 in 1 BOTTLE TABLET, DELAYED RELEASE 14 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OMEPRAZOLE ACTIVE INGREDIENT KG60484QX9 EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 OMEPRAZOLE ACTIVE MOIETY KG60484QX9 EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 MONOETHANOLAMINE INACTIVE INGREDIENT 5KV86114PT EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 SODIUM STEARATE INACTIVE INGREDIENT QU7E2XA9TG EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM EQUATE OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-119 EQUATE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WAL-MART STORES INC] 6 Current NDC, Legacy NDC, 4 package rows 20250327_504b8282-d93f-454f-9f93-84cb8a9105d7.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49035-119-01 49035011901 1 BOTTLE in 1 CARTON (49035-119-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 1 bottle 2015-09-02 0000-00-00 No No Current 49035-119-03 49035011903 3 BOTTLE in 1 CARTON (49035-119-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 3 bottle 2015-09-02 0000-00-00 No No Current