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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-2199-4	2023-04-24	These 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
68071-2199-6	2023-04-24	These 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
68071-2199-7	2023-04-24	These 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
68071-2199-9	2023-04-24	These 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
68071-2199-4	2023-01-30	These 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
68071-2199-6	2023-01-30	These 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
68071-2199-7	2023-01-30	These 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
68071-2199-9	2023-01-30	These 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
68071-2199-4	2021-02-23	These 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
68071-2199-6	2021-02-23	These 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
68071-2199-7	2021-02-23	These 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
68071-2199-9	2021-02-23	These 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
68071-2199-4	2021-01-29	These 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
68071-2199-6	2021-01-29	These 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
68071-2199-7	2021-01-29	These 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
68071-2199-9	2021-01-29	These 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 NDC	Product	Description	Form	Quantity	SPL version
68071-2199-4	Omeprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	6
68071-2199-6	Omeprazole	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	6
68071-2199-7	Omeprazole	7 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	7	6
68071-2199-9	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2199	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NUCAREPHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 4 package rows	20240719_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 87 of 117 · 2,322 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	ZO Skin Health, Inc.	9a4f5be1-da04-48b9-897a-57f4a3d9d1ec	2024-10-29	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Broad-Spectrum Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health, Inc.	d817f80b-a998-b67e-e053-2995a90a1971	2024-10-29	Warnings	Exact identifier unii: 15FIX9V2JP
Banana Boat Kids Mineral Protection SPF50	TITANIUM DIOXIDE,ZINC OXIDE	Edgewell Personal Care Brands LLC	dc7701b5-0c73-b4df-e053-2a95a90a0f1b	2024-10-27	Warnings	Exact identifier unii: 15FIX9V2JP
Banana Boat Mineral Sensitive SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands LLC	dc7913d5-58f2-3077-e053-2a95a90a1627	2024-10-27	Warnings	Exact identifier unii: 15FIX9V2JP
Banana Boat Mineral Sensitive Face SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands LLC	dc783438-b28f-b7f4-e053-2a95a90a3d65	2024-10-27	Warnings	Exact identifier unii: 15FIX9V2JP
Banana Boat Sport Mineral SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands LLC	dc79790f-e2bc-5414-e053-2a95a90a9e7a	2024-10-27	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO Mineral Stick - Tinted SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	fd6d0080-0bef-4e7e-8ca5-b859639efd0c	2024-10-25	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO Mineral Stick Non-Tinted SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	e7044f18-992a-4f60-9a2b-f11ed06db09b	2024-10-25	Warnings	Exact identifier unii: 15FIX9V2JP
CoTZ Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	479a7d82-a068-4c2e-b50b-555c40e13e37	2024-10-25	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO Mineral Sun Defense SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	e17a8c35-2d49-4c99-b154-ea673c14753e	2024-10-25	Warnings	Exact identifier unii: 15FIX9V2JP
IPKN Moist and Firm Beauty Balm Light Medium	TITANIUM DIOXIDE	Inel Cosmetics Co., Ltd.	1af6184e-3dc4-4eb3-8d51-aca724473451	2024-10-25	Warnings	Exact identifier unii: 15FIX9V2JP
IPKN Moist and Firm Beauty Balm Light	TITANIUM DIOXIDE	Inel Cosmetics Co., Ltd.	77d77838-aa13-4939-a1a0-50189fbb3fe0	2024-10-25	Warnings	Exact identifier unii: 15FIX9V2JP
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	ScieGen Pharmaceuticals, Inc.	a107804e-b308-4e79-9447-07d93016f70f	2024-10-24	Warnings, Adverse reactions	Exact identifier unii: KG60484QX9
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44N	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Rare Beauty, LLC	cffbb6af-5a04-f58a-e053-2995a90a1ae2	2024-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Banana Boat	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands, LLC	441a46f0-ecda-4448-e054-00144ff88e88	2024-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28C	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Rare Beauty, LLC	cffb8219-7076-de64-e053-2a95a90a6036	2024-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10N	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Rare Beauty, LLC	cfee02eb-92f9-be12-e053-2a95a90a4337	2024-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
CVS Health 60 Plus Sensitive Skin Sun	TITANIUM DIOXIDE, ZINC OXIDE	CVS Pharmacy	477c25ec-33db-04a6-e054-00144ff8d46c	2024-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bali Body Tinted Super Serum Natural SPF 30	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Bali Body Pty Ltd	f5eeaf37-33f2-2c0c-e053-2a95a90abcc0	2024-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f42a0b1e-038d-4fab-e053-2995a90a5364	2024-10-18	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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