being well omeprazole

Product NDC
46994-915
11-digit product format
469940915
Labeler code
46994
Product ID
46994-915_16f8e91c-5f0c-4664-ab5b-72b426d50a5b
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Save-A-Lot Food Stores Ltd
Application
NDA022032
Marketing category
NDA
Marketing start
2008-03-20
Marketing end
2022-10-01
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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct46994-915DDiscontinued by firm2026-07-31
excluded packagepackage46994-91546994-915-74DDiscontinued by firm2026-07-31

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
Berkley and Jensen OmeprazoleOMEPRAZOLEBJWCf74752a8-a686-4c7d-91ad-8c87c4596a7a2026-05-21WarningsExact identifier
care one omeprazoleOMEPRAZOLEAmerican Sales Companydb2d75ea-5924-4b7f-a92d-d4847a010d522026-04-17WarningsExact identifier
omeprazoleOMEPRAZOLERite Aid Corporationee853401-b641-4dab-b708-29424c2d0b792026-03-25WarningsExact identifier
omeprazoleOMEPRAZOLEHyVee Inca5df7dac-00f4-4d97-9586-cde3055890ac2026-02-04WarningsExact identifier
omeprazoleOMEPRAZOLEHyVee Inccf9919e6-a839-4bad-a007-80d5bf6f81db2026-01-30WarningsExact identifier
good neighbor pharmacy omeprazoleOMEPRAZOLEAmerisource Bergenf9aab207-d309-49b5-b941-c2912b1865832025-12-21WarningsExact identifier
omeprazoleOMEPRAZOLEKroger Company015b1c8f-9d5b-4afc-a55c-1a731b5fc72a2025-12-08WarningsExact identifier
dg health omeprazoleOMEPRAZOLEDolgencorp, LLC326bf21c-fad4-473e-9e7f-797319d4353a2025-09-02WarningsExact identifier
omeprazoleOMEPRAZOLEKroger Companyda18d91c-5fe9-44d4-9d6f-602900af3f082025-06-04WarningsExact identifier
careone omeprazoleOMEPRAZOLERetail Business Services, LLC063cfad8-3ca6-4b72-a4c9-512b8047bae32025-04-17WarningsExact identifier
leader omeprazoleOMEPRAZOLECardinal Health 110, LLC. dba Leader19beab17-ca25-4be3-bada-20a2e9aa26b52025-04-16WarningsExact identifier
rugby omeprazoleOMEPRAZOLERugby Laboratories61952807-f38d-4e7a-8646-a8ec85d7fb372025-04-15WarningsExact identifier
careone omeprazoleOMEPRAZOLEAmerican Sales Companya5ec923a-dbc7-43e0-b3b8-f61dcaa6765d2025-04-14WarningsExact identifier
signature care omeprazoleOMEPRAZOLESafeway85ece978-3cfb-4c09-bf0f-3217fda8e7d42025-04-14WarningsExact identifier
equate omeprazoleOMEPRAZOLEWALMART INC.dcfe8e94-9c88-464e-9a80-3baa9c4755d92025-03-27WarningsExact identifier
equate omeprazoleOMEPRAZOLEWal-Mart Stores Inc504b8282-d93f-454f-9f93-84cb8a9105d72025-03-25WarningsExact identifier
omeprazoleOMEPRAZOLEH E B501d80c0-68ee-4fd9-bc56-0b214dbf72b52025-02-27WarningsExact identifier
omeprazoleOMEPRAZOLEPadagis Israel Pharmaceuticals Ltdcb47354c-297b-4dc2-85af-242acc967b562025-02-06WarningsExact identifier
Signature Care OmeprazoleOMEPRAZOLESafeway6361a492-782f-4608-a20f-1bd86afbd8642025-02-06WarningsExact identifier
omeprazoleOMEPRAZOLEH E B5ceaec04-3ca3-4c7c-9184-51a42686a5952025-02-05WarningsExact 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).

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9BEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
OMEPRAZOLEACTIVE MOIETYKG60484QX9BEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTBEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGBEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIBEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
TALCINACTIVE INGREDIENT7SEV7J4R1UBEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBEING WELL OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAVE-A-LOT FOOD STORES LTD]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46994-915-744699409157414 BLISTER PACK in 1 CARTON (46994-915-74) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2008-03-200000-00-00NoNoCurrent