NDC 59651-003-10 - Omeprazole

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
59651-003
Requested NDC
59651-003-10
Package NDCs from labels
59651-003-30, 59651-003-90, 59651-003-01, 59651-003-05, 59651-003-99, 59651-003-10, 59651-003-03, 59651-003-78
Manufacturer
Aurobindo Pharma Limited
Effective date
2024-06-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Omeprazole - Aurobindo Pharma LimitedAurobindo Pharma Limited2024-06-17Human Prescription Drug Label
Omeprazole - A-S Medication SolutionsA-S Medication Solutions2019-03-25Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-003-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10019
59651-003-03Omeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE319
59651-003-05Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50019
59651-003-10Omeprazole10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1019
59651-003-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3019
59651-003-78Omeprazole10 in 1 CARTONCAPSULE, DELAYED RELEASE1019
59651-003-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9019
59651-003-99Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-003OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]19Current NDC, Legacy NDC, 8 package rows20240618_934601b6-fbba-43c4-a8ef-7a7dfe9f9a51.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-003-05EA - Each59651-00366a41412-7ee6-4328-87db-8c0c66c6afa712018-07-03
59651-003-30EA - Each59651-003c8e7f726-233b-4482-808f-26b0608b638d12019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 125 · 2,498 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Smelling SaltAMMONIAShenzhen Jufeng Qisheng Technology Co., Ltd.44e1b2c1-f524-782c-e063-6394a90ad1e42026-08-18WarningsExact identifier
unii: 5138Q19F1X
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEDiscount Drug Mart, Inc4d5f30c2-775d-a1a3-e063-6394a90a07ff2026-08-12WarningsExact identifier
unii: KG60484QX9
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
GoodMeds 24HR Acid Reducer Omeprazole 20mgOMEPRAZOLE 20MGCabinet Health P.B.C.58c9c8ef-b929-14eb-e063-6294a90a37612026-08-11WarningsExact identifier
unii: KG60484QX9
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
OMEPRAZOLEOMEPRAZOLEH E B4eb05eb3-be59-4132-95a8-5a8f5065d7582026-08-10WarningsExact identifier
rxcui: 198051
unii: KG60484QX9
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.ded0df8b-1813-4595-ac2b-5499704bfd482026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
OmeprazoleOMEPRAZOLEA-S Medication Solutions6ea9a6f3-b756-4cdf-b3db-f666a2c17d662026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.