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 70 of 117 · 2,322 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC40f66cac-bc23-43f9-9966-87cce458c9962025-02-17Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2082aa-5ae3-2c04-e063-6294a90a140b2025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21f5bb-e7df-b43b-e063-6394a90a0f822025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2102c6-02ea-3a8f-e063-6394a90abf5e2025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2297d4-3649-a749-e063-6294a90ac2842025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e22cfde-10a1-3742-e063-6394a90ac0972025-02-14WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEAsclemed USA, Inc.9c41bcfa-b08b-3ac3-e053-2a95a90ae1c02025-02-13Warnings, Adverse reactionsExact identifier
application number: ANDA091672
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
Neutrogena Mineral Ultra Sheer Dry Touch SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCe99311c2-ed8b-6e60-e053-2a95a90a9bc22025-02-13WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEChartwell RX, LLC4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e2025-02-12Warnings, Adverse reactionsExact identifier
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC2dcd48e4-9ffc-9cc2-e063-6294a90ae17e2025-02-10Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen DeepENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp88021a24-d3b5-48f8-8d26-affbfcfd098f2025-02-10WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2dd20800-2cf9-02d4-e063-6294a90a0f002025-02-10WarningsExact identifier
unii: 15FIX9V2JP
Centella Calming SUNSCREENCENTELLA CALMING SUNSCREENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd2dc0ee9b-d58b-fe40-e063-6394a90af4392025-02-09WarningsExact identifier
unii: 15FIX9V2JP
PROBIOTIC RICE SunscreenPROBIOTIC RICE SUNSCREENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd2d9d6440-39b3-312a-e063-6394a90aa0722025-02-08WarningsExact identifier
unii: 15FIX9V2JP
DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENTZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.01cfe6a6-c2e4-8fb8-e063-6294a90adc782025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a8bab8-ca5d-6b65-e063-6294a90abb072025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a82029-bdb1-cbe0-e063-6294a90a08f32025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a87c6b-3c7d-5942-e063-6294a90aa4522025-02-06WarningsExact identifier
unii: 15FIX9V2JP
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.02a671ed-485d-d6b7-e063-6394a90ad4af2025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Cicapair Tiger Grass Camo DropsZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.01cf0522-a3c1-aea8-e063-6294a90aabfe2025-02-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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