FDA.reportPublic FDA data

Sofosbuvir and Velpatasvir

Product NDC
72626-2701
11-digit product format
726262701
Labeler code
72626
Product ID
72626-2701_314b9ef7-c6e5-44c9-9fbf-b0d35a24cd7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Velpatasvir and Sofosbuvir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asegua Therapeutics LLC
Application
NDA208341
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-11-14
Substance
SOFOSBUVIR; VELPATASVIR
Active strength
400; 100 mg/1; mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Hepatitis C Virus NS5A Inhibitor [EPC], Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], RNA Replicase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sofosbuvir and Velpatasvir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOFOSBUVIR400 mg/1
VELPATASVIR100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWJ6CA3ZU8B, KCU0C7RS7Z
Rxcui1799212

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
92f2ba3e-4d65-41e6-a610-6d4b30045f53Product name320220118
4b0175e6-7a5b-49b7-bb68-cb6baadf8704Product name220200213
67bfd237-f3a6-4139-9e2c-fe97fb0f8bc0Product name220200213
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a9351c76-435b-43d8-966c-be983b09b034Product name120170816
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72626-2701-12025-03-06C16284748780-12cef2736-9aec-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use SOFOSBUVIR and VELPATASVIR TABLETS safely and effectively. See full prescribing information for SOFOSBUVIR and VELPATASVIR TABLETS. SOFOSBUVIR and VELPATASVIR tablets, for oral use, 400 mg/100 mg (Authorized generic of EPCLUSA ® ) Initial U.S. Approval: 2016
72626-2701-12025-01-30C16284748780-12cef2736-9aec-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use SOFOSBUVIR and VELPATASVIR TABLETS safely and effectively. See full prescribing information for SOFOSBUVIR and VELPATASVIR TABLETS. SOFOSBUVIR and VELPATASVIR tablets, for oral use, 400 mg/100 mg (Authorized generic of EPCLUSA ® ) Initial U.S. Approval: 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72626-2701-1Sofosbuvir and Velpatasvir2 in 1 CARTONTABLET, FILM COATED29
72626-2701-1Sofosbuvir and Velpatasvir14 in 1 BLISTER PACKTABLET, FILM COATED149

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72626-2701-1EA - Each72626-27016bcf904a-1ed7-4476-abc7-75bd71caf60412018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72626-2701SOFOSBUVIR AND VELPATASVIR (VELPATASVIR AND SOFOSBUVIR) TABLET, FILM COATED [ASEGUA THERAPEUTICS LLC]9Current NDC, Legacy NDC, 2 package rows20250309_d0c1a945-4440-4b5c-81aa-693ed3db597c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1799212sofosbuvir 400 MG / velpatasvir 100 MG Oral TabletPSNd0c1a945-4440-4b5c-81aa-693ed3db597c9
1799212sofosbuvir 400 MG / velpatasvir 100 MG Oral TabletSCDd0c1a945-4440-4b5c-81aa-693ed3db597c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72626-2701-1726262701012 BLISTER PACK in 1 CARTON (72626-2701-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2018-11-140000-00-00NoNoCurrent