Tembexa

Product NDC
79622-012
11-digit product format
796220012
Labeler code
79622
Product ID
79622-012_2f140fb3-5828-484b-b006-529b7f31c036
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brincidofovir
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chimerix, Inc.
Application
NDA214460
Marketing category
NDA
Marketing start
2022-04-20
Marketing end
0000-00-00
Substance
BRINCIDOFOVIR
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
1625e783-d316-4f61-a95a-9e96a8159086Product name120220118
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
cff38427-72e6-4268-92d0-25b276bf1896Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79622-012-65Tembexa65 mL in 1 BOTTLESUSPENSION654
79622-012-70Tembexa65 mL in 1 BOTTLESUSPENSION654

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79622-012-65ML - Milliliter79622-01238d9d1ca-602d-4deb-bef7-5bdab4ded0ed12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79622-012TEMBEXA (BRINCIDOFOVIR) SUSPENSION [CHIMERIX, INC.]4Legacy NDC, 2 package rows20220422_12569e7c-9c2a-4b8b-94e2-f05607b4a866.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2599525brincidofovir 10 MG/mL Oral SuspensionPSN12569e7c-9c2a-4b8b-94e2-f05607b4a8664
2599531TEMBEXA 10 MG/mL Oral SuspensionPSN12569e7c-9c2a-4b8b-94e2-f05607b4a8664
2599531brincidofovir 10 MG/ML Oral Suspension [Tembexa]SBD12569e7c-9c2a-4b8b-94e2-f05607b4a8664
2599525brincidofovir 10 MG/ML Oral SuspensionSCD12569e7c-9c2a-4b8b-94e2-f05607b4a8664
2599531Tembexa 10 MG/ML Oral SuspensionSY12569e7c-9c2a-4b8b-94e2-f05607b4a8664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79622-012-657962200126565 mL in 1 BOTTLE (79622-012-65) 65 ml2022-04-200000-00-00NoNoCurrent
79622-012-707962200127065 mL in 1 BOTTLE (79622-012-70) 65 ml2022-04-200000-00-00NoNoCurrent