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 82 of 117 · 2,322 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Corrector Palette SPF 20 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	ab70122f-bd68-4781-841f-dc83284e1403	2024-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 10	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	0a0654cc-ad47-2167-e063-6294a90a52f4	2024-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40	ZINC OXIDE, TITANIUM DIOXIDE	Babo Botanicals, Inc.	f8adda52-e909-1905-e053-6294a90a3c78	2024-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Babo Botanicals SPF 30 Daily Sheer Tinted Sunscreen - Natural Glow	MINERAL SUNSCREEN	Babo Botanicals, Inc.	ab39d9f0-d869-6f33-e053-2995a90a08d4	2024-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Alumier MD Sheer Hydration	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	88dedeb8-963f-5849-e053-2995a90aab72	2024-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
All Calm Clinical Redness Corrector SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	68b95e94-3686-4d11-9952-ec86394376ee	2024-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	219e2ef4-e977-4527-8999-14b27d5a7a33	2024-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	ee9ae84b-c8fc-4a87-8910-46ec8ccfe1a9	2024-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG DORE SPF 20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	121aa873-5ca6-426b-8ece-dcb5a9f82a03	2024-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN - CC CREME HIGH DEFINITION SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	3421b9a3-6551-406f-af3a-b3da8a01d2b2	2024-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN CC RED CORRECT SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	Laboratoires M&L	21530925-03b7-40bb-9836-6ee4011c4a79	2024-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	70a5537c-a364-4dae-8ab2-8ca0cbfd11b7	2024-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	b55be8cb-7f21-45b0-bb8f-a60182077ca3	2024-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Deep Honey	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	dc792777-d8b6-3ebc-e053-2a95a90abc3f	2024-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	064b1418-0f42-4b18-9dee-cda40c5e1fca	2024-12-11	Warnings, Adverse reactions	Exact identifier rxcui: 198051 unii: KG60484QX9
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	c311c1b9-8ec2-4ac0-baa2-a5063fba2d80	2024-12-11	Warnings, Adverse reactions	Exact identifier rxcui: 200329 unii: KG60484QX9
Tinted Sunscreen Cream SPF 30 4-Deep Amber	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	5599922a-b020-477c-a44c-1db42ec5756a	2024-12-10	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Sunscreen SPF 30 1-Natural	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	b3d53a10-2647-492a-a05f-b97c3f716aa8	2024-12-10	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Sunscreen SPF 30 2-Golden	TITANIUM DIOXIDE, ZINC OXIDE	C.F.E.B. - Sisley	389cbce6-552c-4633-babd-7b672632f0b9	2024-12-10	Warnings	Exact identifier unii: 15FIX9V2JP
Prevention Daily Tinted Moisturizer SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	ed883d63-777c-e924-e053-2995a90a162a	2024-12-09	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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