FDA.reportPublic FDA data

Ledipasvir and Sofosbuvir

Product NDC
72626-2601
11-digit product format
726262601
Labeler code
72626
Product ID
72626-2601_bd8387fe-8338-4241-b084-aec76726f8a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ledipasvir and Sofosbuvir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asegua Therapeutics LLC
Application
NDA205834
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-01-01
Substance
LEDIPASVIR; SOFOSBUVIR
Active strength
90; 400 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], 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
Ledipasvir and Sofosbuvir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEDIPASVIR90 mg/1
SOFOSBUVIR400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii013TE6E4WV, WJ6CA3ZU8B
Rxcui1591943

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72626-2601-1Ledipasvir and Sofosbuvir14 in 1 BLISTER PACKTABLET, FILM COATED148
72626-2601-1Ledipasvir and Sofosbuvir2 in 1 CARTONTABLET, FILM COATED28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72626-2601-1EA - Each72626-260156402075-af5d-4c17-90c4-18faca0ea19712018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72626-2601LEDIPASVIR AND SOFOSBUVIR TABLET, FILM COATED [ASEGUA THERAPEUTICS LLC]8Current NDC, Legacy NDC, 2 package rows20250119_46f4a73b-0cd6-4902-9092-3ac79e882c1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1591943ledipasvir 90 MG / sofosbuvir 400 MG Oral TabletPSN46f4a73b-0cd6-4902-9092-3ac79e882c1a8
1591943ledipasvir 90 MG / sofosbuvir 400 MG Oral TabletSCD46f4a73b-0cd6-4902-9092-3ac79e882c1a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72626-2601-1726262601012 BLISTER PACK in 1 CARTON (72626-2601-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2019-01-010000-00-00NoNoCurrent