FDA.reportPublic FDA data

VYKOURA

Product NDC
83831-147
11-digit product format
838310147
Labeler code
83831
Product ID
83831-147_c655613e-4381-461e-8e2d-4121be761c04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
leucovorin calcium
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Avyxa Pharma, LLC
Application
NDA220406
Marketing category
NDA
Marketing start
2026-03-16
Substance
LEUCOVORIN CALCIUM
Active strength
50 mg/5mL
Pharmacologic classes
Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VYKOURA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUCOVORIN CALCIUM50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRPR1R4C0P4
Rxcui2104714, 2735355, 2735359, 2735364, 2735365, 2735366

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
31adef49-84cb-4c51-b122-69e924e10ea3Product name420240827
df40773e-fe5a-474c-8d32-d19c7094e396Product name220240813
cd1aa5b9-18a7-4dc4-8a13-b5c677c859a2Product name120231116
38866763-6a8e-4096-95c3-082a000c243dProduct name120230809
7ce39568-aceb-b33a-23ed-c4964cdcf486Product name220210211
6c712ad1-eecf-448f-84d9-5c0c307a7112Product name120161130

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83831-147-05VYKOURA5 mL in 1 VIAL, SINGLE-USEINJECTION57
83831-147-05VYKOURA1 in 1 CARTONINJECTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83831-147-05ML - Milliliter83831-14724d2e82a-5c83-4a99-a721-e6bdc824a41a12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2735355leucovorin 350 MG in 35 ML InjectionPSNd122b875-435e-4e00-b945-7a0546df95c27
2735364leucovorin 50 MG in 5 ML InjectionPSNd122b875-435e-4e00-b945-7a0546df95c27
2104714leucovorin 500 MG in 50 ML InjectionPSNd122b875-435e-4e00-b945-7a0546df95c27
2735359VYKOURA 350 MG in 35 ML InjectionPSNd122b875-435e-4e00-b945-7a0546df95c27
2735365VYKOURA 50 MG in 5 ML InjectionPSNd122b875-435e-4e00-b945-7a0546df95c27
2735366VYKOURA 500 MG in 50 ML InjectionPSNd122b875-435e-4e00-b945-7a0546df95c27
273535935 ML leucovorin 10 MG/ML Injection [Vykoura]SBDd122b875-435e-4e00-b945-7a0546df95c27
27353655 ML leucovorin 10 MG/ML Injection [Vykoura]SBDd122b875-435e-4e00-b945-7a0546df95c27
273536650 ML leucovorin 10 MG/ML Injection [Vykoura]SBDd122b875-435e-4e00-b945-7a0546df95c27
273535535 ML leucovorin 10 MG/ML InjectionSCDd122b875-435e-4e00-b945-7a0546df95c27
27353645 ML leucovorin 10 MG/ML InjectionSCDd122b875-435e-4e00-b945-7a0546df95c27
210471450 ML leucovorin 10 MG/ML InjectionSCDd122b875-435e-4e00-b945-7a0546df95c27
2104714leucovorin (as leucovorin calcium) 500 MG per 50 ML InjectionSYd122b875-435e-4e00-b945-7a0546df95c27
2735355leucovorin 350 MG per 35 ML InjectionSYd122b875-435e-4e00-b945-7a0546df95c27
2735364leucovorin 50 MG per 5 ML InjectionSYd122b875-435e-4e00-b945-7a0546df95c27
2104714leucovorin 500 MG per 50 ML InjectionSYd122b875-435e-4e00-b945-7a0546df95c27
2735359Vykoura 350 MG per 35 ML InjectionSYd122b875-435e-4e00-b945-7a0546df95c27
2735365Vykoura 50 MG per 5 ML InjectionSYd122b875-435e-4e00-b945-7a0546df95c27
2735366Vykoura 500 MG per 50 ML InjectionSYd122b875-435e-4e00-b945-7a0546df95c27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83831-147-05838310147051 VIAL, SINGLE-USE in 1 CARTON (83831-147-05) / 5 mL in 1 VIAL, SINGLE-USE2026-03-16NoNoCurrent