NDC 68071-2199-07 - 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
68071-2199
Requested NDC
68071-2199-07
Package NDCs from labels
68071-2199-7, 68071-2199-4, 68071-2199-6, 68071-2199-9, 68071-2199-07
Manufacturer
NuCarePharmaceuticals, Inc. | NuCare Pharmaceuticals, Inc.
Effective date
2024-07-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Omeprazole - NuCarePharmaceuticals, Inc. | NuCare Pharmaceuticals, Inc.NuCarePharmaceuticals, Inc. | NuCare Pharmaceuticals, Inc.2024-07-17HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-2199-42023-04-24These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-62023-04-24These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-72023-04-24These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-92023-04-24These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-42023-01-30These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-62023-01-30These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-72023-01-30These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-92023-01-30These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-42021-02-23These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-62021-02-23These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-72021-02-23These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-92021-02-23These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-42021-01-29These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-62021-01-29These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-72021-01-29These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
68071-2199-92021-01-29These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2199-4Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE146
68071-2199-6Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
68071-2199-7Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE76
68071-2199-9Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2199OMEPRAZOLE CAPSULE, DELAYED RELEASE [NUCAREPHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 4 package rows20240719_4be616c4-1b9a-5654-e054-00144ff88e88.zip

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 3 of 118 · 2,356 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.0344268f-d8e6-48d5-b1e1-f750ed1d8a522026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEHAWAII REPACK, INC.9359e826-5263-44fc-8dd3-9d0852fe42d62026-07-13Warnings, Adverse reactionsExact identifier
application number: ANDA091672
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepackdcaadc8c-32d1-476f-b821-973c012b7fa72026-07-10Warnings, Adverse reactionsExact identifier
application number: ANDA091672
rxcui: 198051
unii: KG60484QX9
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
careone omeprazoleOMEPRAZOLEAmerican Sales Company5b88717a-e90c-4e74-ae2a-29270e14a3cc2026-07-08WarningsExact identifier
unii: KG60484QX9
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
OmeprazoleOMEPRAZOLE MAGNESIUMYYBA CORP535c2543-84f3-f5c1-e063-6394a90adb1e2026-07-07WarningsExact identifier
rxcui: 198051
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacy4c0cf466-f9e8-390e-e063-6294a90a2ed82026-07-02Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEUnit Dose Solutions, Inc.557d4c2c-5541-3a51-e063-6394a90ad2782026-06-30Warnings, Adverse reactionsExact identifier
application number: ANDA091672
rxcui: 198051
unii: KG60484QX9
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
GOOD SENSE OMEPRAZOLEOMEPRAZOLEL. Perrigo Companyb840439b-540b-465a-8faa-f7b1024c628e2026-06-29WarningsExact identifier
rxcui: 198051
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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