NDC 50072-010-30 - TPOXX

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
50072-010
Requested NDC
50072-010-30
Package NDCs from labels
50072-010-30, 50072-010-01
Manufacturer
SIGA Technologies, Inc. | Catalent Pharma Solutions, LLC
Effective date
2025-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TPOXX - SIGA Technologies, Inc. | Catalent Pharma Solutions, LLCSIGA Technologies, Inc. | Catalent Pharma Solutions, LLC2025-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50072-010-01TPOXX7 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE717
50072-010-30TPOXX20 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE2017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50072-010TPOXX (TECOVIRIMAT MONOHYDRATE) INJECTION, SOLUTION, CONCENTRATE TPOXX (TECOVIRIMAT MONOHYDRATE) CAPSULE [SIGA TECHNOLOGIES, INC.]16Current NDC, Legacy NDC, 2 package rows20240718_fce826ab-4d6a-4139-a2ee-a304a913a253.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50072-010-01ML - Milliliter50072-010c0262f0e-79f5-4df2-a7eb-00a0a0227f2312022-08-04
50072-010-30ML - Milliliter50072-0102a442f00-793e-4454-9e45-095421082b1f12022-06-06

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 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TPOXXTECOVIRIMAT MONOHYDRATESIGA Technologies, Inc.fce826ab-4d6a-4139-a2ee-a304a913a2532025-12-31Warnings, Adverse reactionsExact identifier
application number: NDA208627
application number: NDA214518
ndc (package): 50072-200-42
ndc (package): 50072-010-01
ndc (package): 50072-010-30
ndc (product): 50072-010
ndc (product): 50072-200
ndc11 (package): 50072001030
rxcui: 2602126
rxcui: 2055115
rxcui: 2602131
rxcui: 2055109
spl id: 474526fb-5357-880e-e063-6294a90a3296
spl set id: fce826ab-4d6a-4139-a2ee-a304a913a253
unii: F925RR824R
unii: SB96YO2BR8

Reported adverse events (FAERS/openFDA)#

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