FDA.reportPublic FDA data

NDC 0010-4492-01 - Semintra

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
0010-4492
Requested NDC
0010-4492-01
Package NDCs from labels
0010-4492-01
Manufacturer
Boehringer Ingelheim Animal Health USA Inc.
Effective date
2021-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Semintra® (telmisartan oral solution) 10 mg/mLBoehringer Ingelheim Animal Health USA Inc.2021-08-25PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0010-4492-01Semintra35 mL in 1 BOTTLE, PLASTICSOLUTION353
0010-4492-01Semintra1 in 1 CARTONSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0010-4492SEMINTRA (TELMISARTAN) SOLUTION [BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.]32 package rows20210826_f436a826-9f5b-4269-b4ec-97d5522eaca6.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 3 · 51 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TelmisartanTELMISARTANAmneal Pharmaceuticals LLC20a60231-64f0-4751-aa81-6c0e643341792023-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANModavar Pharmaceuticals LLCa075633a-2a2a-4e88-8ede-b49a3920a16c2023-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANA-S Medication Solutions509cd338-24db-41d1-a115-9dc9991707172023-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.e80f232c-c1c4-4524-a0a5-d23ee0d1f3b72023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANCadila Pharmaceuticals Limited353fcb30-2fa7-4ff1-8a18-26f3ec279d002023-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANAmneal Pharmaceuticals of New York LLCbf2dca37-ce9c-40e4-8ad6-b8186aa7fed12023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
TelmisartanTELMISARTANMylan Pharmaceuticals Inc.c3658bc8-1524-43db-930e-66f9ac01b8082023-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEAlembic Pharmaceuticals Limited15b438b4-4874-43f4-a50a-4e6f3e5530ac2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited5b476740-e3f0-4f68-b07c-cd9eb2fa27ca2023-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
telmisartanTELMISARTANProficient Rx LP593a53a4-91bc-4e4a-aeff-08fc2efe3dd42020-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEMylan Pharmaceuticals Inc.ca60a4d5-ace7-4889-94ee-e2265fd638112018-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U5SYW473RQ

Reported adverse events (FAERS/openFDA)#

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