FDA.reportPublic FDA data

Epclusa

Product NDC
61958-2201
11-digit product format
619582201
Labeler code
61958
Product ID
61958-2201_4e28b652-df20-450d-9f6e-4cc6e355e223
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Velpatasvir and Sofosbuvir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Gilead Sciences, Inc.
Application
NDA208341
Marketing category
NDA
Marketing start
2016-06-28
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
Epclusa
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKCU0C7RS7Z, WJ6CA3ZU8B
Rxcui1799212, 1799218, 2288814, 2288816, 2584196, 2584199, 2584200, 2584201

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
92f2ba3e-4d65-41e6-a610-6d4b30045f53Product name320220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-2201-1Epclusa28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-2201-1EA - Each61958-220191a51bae-55bf-4595-aa48-1bce4691991d12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-2201EPCLUSA (VELPATASVIR AND SOFOSBUVIR) TABLET, FILM COATED EPCLUSA (VELPATASVIR AND SOFOSBUVIR) PELLET [GILEAD SCIENCES, INC.]14Current NDC, Legacy NDC, 1 package rows20250206_7f30631a-ee3b-4cfe-866b-964df3f0a44f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2584199Epclusa 150 MG / 37.5 MG Oral PelletPSN7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2584201Epclusa 200 MG / 50 MG Oral PelletPSN7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2288816Epclusa 200 MG / 50 MG Oral TabletPSN7f30631a-ee3b-4cfe-866b-964df3f0a44f14
1799218Epclusa 400 MG / 100 MG Oral TabletPSN7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2584196sofosbuvir 150 MG / velpatasvir 37.5 MG Oral PelletPSN7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2584200sofosbuvir 200 MG / velpatasvir 50 MG Oral PelletPSN7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2288814sofosbuvir 200 MG / velpatasvir 50 MG Oral TabletPSN7f30631a-ee3b-4cfe-866b-964df3f0a44f14
1799212sofosbuvir 400 MG / velpatasvir 100 MG Oral TabletPSN7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2584199sofosbuvir 150 MG / velpatasvir 37.5 MG Oral Pellet [Epclusa]SBD7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2584201sofosbuvir 200 MG / velpatasvir 50 MG Oral Pellet [Epclusa]SBD7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2288816sofosbuvir 200 MG / velpatasvir 50 MG Oral Tablet [Epclusa]SBD7f30631a-ee3b-4cfe-866b-964df3f0a44f14
1799218sofosbuvir 400 MG / velpatasvir 100 MG Oral Tablet [Epclusa]SBD7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2584196sofosbuvir 150 MG / velpatasvir 37.5 MG Oral PelletSCD7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2584200sofosbuvir 200 MG / velpatasvir 50 MG Oral PelletSCD7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2288814sofosbuvir 200 MG / velpatasvir 50 MG Oral TabletSCD7f30631a-ee3b-4cfe-866b-964df3f0a44f14
1799212sofosbuvir 400 MG / velpatasvir 100 MG Oral TabletSCD7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2584199Epclusa (sofosbuvir 150 MG / velpatasvir 37.5 MG) Oral PelletSY7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2584201Epclusa (sofosbuvir 200 MG / velpatasvir 50 MG) Oral PelletSY7f30631a-ee3b-4cfe-866b-964df3f0a44f14
2288816Epclusa (sofosbuvir 200 MG / velpatasvir 50 MG) Oral TabletSY7f30631a-ee3b-4cfe-866b-964df3f0a44f14
1799218Epclusa (sofosbuvir 400 MG / velpatasvir 100 MG) Oral TabletSY7f30631a-ee3b-4cfe-866b-964df3f0a44f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61958-2201-16195822010128 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2201-1) 2016-06-280000-00-00NoNoCurrent