FDA.reportPublic FDA data

NDC 0010-9719 - ULCERGARD

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
0010-9719
Package NDCs from labels
0010-9719-01, 0010-9719-02
Manufacturer
Boehringer Ingelheim Animal Health USA Inc.
Effective date
2020-10-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ulcergard® (omeprazole) Oral Paste for HorsesBoehringer Ingelheim Animal Health USA Inc.2020-10-09OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0010-9719-01ULCERGARD1 in 1 CARTONPASTE11
0010-9719-01ULCERGARD6.15 g in 1 SYRINGE, PLASTICPASTE6.151
0010-9719-02ULCERGARD6.15 g in 1 SYRINGE, PLASTICPASTE6.151
0010-9719-02ULCERGARD6 in 1 CARTONPASTE61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0010-9719ULCERGARD (OMEPRAZOLE) PASTE [BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.]14 package rows20201010_1e025933-a354-4cda-84a1-0a0fa81c228a.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 13 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLENorthStar Rx LLCc5af5f4b-17be-7245-b281-f27c878312422023-06-20Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEZydus Pharmaceuticals USA Inc.9c22ceb2-2c34-43c3-9a35-2589c90787412023-05-11Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLESandoz Ince4562da8-9d94-4417-9f80-c1ffd42472592023-04-30Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLELannett Company, Inc.92201fb1-4570-42db-8da3-3b8c0e291d322023-04-21Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEWalgreen Company87cee50d-4c1e-473d-9d70-b1622f84aee12023-03-17WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LPa53ea447-add5-4ed5-aa7e-975b13d90e752023-02-01Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLETHE KROGER COMPANYf55cedc7-e0bc-4d30-af52-bfa881f6adde2023-01-06WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLETwin Med LLC346141b5-b49d-489a-84eb-18df8b9404602023-01-06WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEHARRIS TEETERc618964f-4b16-448e-851b-e6b2a816c6602022-12-27WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLECamber Consumer Care Inc9c856d3a-e38f-4006-a43a-ec1a9fa0f0572022-11-28WarningsExact identifier
unii: KG60484QX9
Omeprazole, Sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEGuardian Drug Companye5c6c2cf-fb3b-456a-a0a0-be396d6f83192022-11-08Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LP9786b04f-f827-460b-91bc-c0ac967f95dd2022-11-01Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEStrategic Sourcing Servicesdfa91081-3917-4dfc-9789-76800f57bb312022-05-11WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LP2d99b4fd-49b3-403d-96a4-0cceda85a95c2022-04-01Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LP2fc5065c-5850-469b-b357-fa4df30a8f782022-04-01Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEXiromed, LLC38bd8e13-591e-f11b-7d8a-11717c56493c2022-02-15Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC4b188d97-f1b3-468d-9818-b8333bf24b5a2020-12-17Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Good Sense Omeprazole and Sodium BicarbonateOMEPRAZOLE, SODIUM BICARBONATEL. Perrigo Companybcf32242-de17-4da1-b707-4ce26262eb782020-11-16WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCa0dc4ffa-db18-4871-9d36-51d02e3b2bd92019-03-20Warnings, Adverse reactionsExact identifier
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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