FDA.reportPublic FDA data

TPOXX

Product NDC
50072-200
11-digit product format
500720200
Labeler code
50072
Product ID
50072-200_474526fb-5357-880e-e063-6294a90a3296
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tecovirimat monohydrate
Dosage form
CAPSULE
Route
ORAL
Labeler
SIGA Technologies, Inc.
Application
NDA208627
Marketing category
NDA
Marketing start
2018-08-31
Substance
TECOVIRIMAT MONOHYDRATE
Active strength
200 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Orthopoxvirus VP37 Envelope Wrapping Protein Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TPOXX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TECOVIRIMAT MONOHYDRATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF925RR824R, SB96YO2BR8
Rxcui2055109, 2055115, 2602126, 2602131

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6d0031fe-7843-4017-9ccc-c35557ac3accProduct name220230125

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50072-200-422026-01-05C16284748780-13b156c62-2939-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use TPOXX ® safely and effectively. See full prescribing information for TPOXX. TPOXX (tecovirimat) capsules, for oral use TPOXX (tecovirimat) injection for intravenous use Initial U.S. Approval: 2018
50072-200-422025-07-29C16284748780-13b156c62-2939-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use TPOXX ® safely and effectively. See full prescribing information for TPOXX. TPOXX (tecovirimat) capsules, for oral use TPOXX (tecovirimat) injection for intravenous use Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50072-200-42TPOXX42 in 1 BOTTLECAPSULE4217

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50072-200-42EA - Each50072-200da1e6e0c-8cff-4f80-801a-fdbc2033e36f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50072-200TPOXX (TECOVIRIMAT MONOHYDRATE) INJECTION, SOLUTION, CONCENTRATE TPOXX (TECOVIRIMAT MONOHYDRATE) CAPSULE [SIGA TECHNOLOGIES, INC.]16Current NDC, Legacy NDC, 1 package rows20240718_fce826ab-4d6a-4139-a2ee-a304a913a253.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2602126tecovirimat 200 MG in 20 ML InjectionPSNfce826ab-4d6a-4139-a2ee-a304a913a25317
2055109tecovirimat 200 MG Oral CapsulePSNfce826ab-4d6a-4139-a2ee-a304a913a25317
2602131TPOXX 200 MG in 20 ML InjectionPSNfce826ab-4d6a-4139-a2ee-a304a913a25317
2055115TPOXX 200 MG Oral CapsulePSNfce826ab-4d6a-4139-a2ee-a304a913a25317
260213120 ML tecovirimat 10 MG/ML Injection [Tpoxx]SBDfce826ab-4d6a-4139-a2ee-a304a913a25317
2055115tecovirimat 200 MG Oral Capsule [Tpoxx]SBDfce826ab-4d6a-4139-a2ee-a304a913a25317
260212620 ML tecovirimat 10 MG/ML InjectionSCDfce826ab-4d6a-4139-a2ee-a304a913a25317
2055109tecovirimat 200 MG Oral CapsuleSCDfce826ab-4d6a-4139-a2ee-a304a913a25317
260213120 ML Tpoxx 10 MG/ML InjectionSYfce826ab-4d6a-4139-a2ee-a304a913a25317
2602126tecovirimat 200 MG per 20 ML InjectionSYfce826ab-4d6a-4139-a2ee-a304a913a25317
2055115Tpoxx 200 MG Oral CapsuleSYfce826ab-4d6a-4139-a2ee-a304a913a25317
2602131Tpoxx 200 MG per 20 ML InjectionSYfce826ab-4d6a-4139-a2ee-a304a913a25317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50072-200-425007202004242 CAPSULE in 1 BOTTLE (50072-200-42) 42 capsule2018-08-310000-00-00NoNoCurrent