FDA.reportPublic FDA data

Veklury

Product NDC
61958-2901
11-digit product format
619582901
Labeler code
61958
Product ID
61958-2901_2399f66f-aacb-4743-8117-b722c91b4bac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
remdesivir
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Gilead Sciences, Inc.
Application
NDA214787
Marketing category
NDA
Marketing start
2020-11-01
Substance
REMDESIVIR
Active strength
100 mg/1
Pharmacologic classes
SARS-CoV-2 Nucleotide Analog RNA Polymerase 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
Veklury
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
REMDESIVIR100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3QKI37EEHE
Rxcui2284960, 2367758, 2395502, 2395504

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99dff68f-b615-4e99-a38a-c795f81730efProduct name120210517

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-2901-2Veklury1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,123
61958-2901-2Veklury1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-2901-1EA - Each61958-290100cbb0d1-e8a5-410f-a0ac-69f7579a76bb12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-2901VEKLURY (REMDESIVIR) INJECTION VEKLURY (REMDESIVIR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GILEAD SCIENCES, INC.]20Current NDC, Legacy NDC, 2 package rows20250126_c0978fa8-53ff-4ca2-82a7-567fd3e958ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2367758remdesivir 100 MG in 20 mL InjectionPSNc0978fa8-53ff-4ca2-82a7-567fd3e958ca23
2284960remdesivir 100 MG InjectionPSNc0978fa8-53ff-4ca2-82a7-567fd3e958ca23
2395504Veklury 100 MG in 20 mL InjectionPSNc0978fa8-53ff-4ca2-82a7-567fd3e958ca23
2395502Veklury 100 MG InjectionPSNc0978fa8-53ff-4ca2-82a7-567fd3e958ca23
239550420 ML remdesivir 5 MG/ML Injection [Veklury]SBDc0978fa8-53ff-4ca2-82a7-567fd3e958ca23
2395502remdesivir 100 MG Injection [Veklury]SBDc0978fa8-53ff-4ca2-82a7-567fd3e958ca23
236775820 ML remdesivir 5 MG/ML InjectionSCDc0978fa8-53ff-4ca2-82a7-567fd3e958ca23
2284960remdesivir 100 MG InjectionSCDc0978fa8-53ff-4ca2-82a7-567fd3e958ca23
239550420 ML Veklury 5 MG/ML InjectionSYc0978fa8-53ff-4ca2-82a7-567fd3e958ca23
2367758remdesivir 100 MG per 20 ML InjectionSYc0978fa8-53ff-4ca2-82a7-567fd3e958ca23
2395502Veklury 100 MG InjectionSYc0978fa8-53ff-4ca2-82a7-567fd3e958ca23
2395504Veklury 100 MG per 20 ML InjectionSYc0978fa8-53ff-4ca2-82a7-567fd3e958ca23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61958-2901-1619582901011 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-1) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2020-05-012023-09-30NoNoCurrent
61958-2901-2619582901021 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2020-11-010000-00-00NoNoCurrent