FDA.reportPublic FDA data

VYKOURA

Product NDC
83831-148
11-digit product format
838310148
Labeler code
83831
Product ID
83831-148_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
350 mg/35mL
Pharmacologic classes
Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220406-001VYKOURALEUCOVORIN CALCIUMEQ 50MG BASE/5ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2026-02-03
N220406-002VYKOURALEUCOVORIN CALCIUMEQ 350MG BASE/35ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2026-02-03
N220406-003VYKOURALEUCOVORIN CALCIUMEQ 500MG BASE/50ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2026-02-03

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220406-001125645922044-12-23Drug product2026-03-05
N220406-002125645922044-12-23Drug product2026-03-05
N220406-003125645922044-12-23Drug product2026-03-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220406-001VYKOURAEQ 50MG BASE/5ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2026-02-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220406-002VYKOURAEQ 350MG BASE/35ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2026-02-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220406-003VYKOURAEQ 500MG BASE/50ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRLD, RS2026-02-03a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220406-001125645922044-12-23Drug product2026-03-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220406-002125645922044-12-23Drug product2026-03-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220406-003125645922044-12-23Drug product2026-03-05a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUCOVORIN CALCIUM350 mg/35mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RPR1R4C0P4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2104714Internal RxNorm lookup
2735355Internal RxNorm lookup
2735359Internal RxNorm lookup
2735364Internal RxNorm lookup
2735365Internal RxNorm lookup
2735366Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d122b875-435e-4e00-b945-7a0546df95c2Available on FDA.report

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
83831-148-35VYKOURA35 mL in 1 VIAL, SINGLE-USEINJECTION357
83831-148-35VYKOURA1 in 1 CARTONINJECTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83831-148-35ML - Milliliter83831-14828415417-61c4-40fb-8015-8f6494a9617312026-03-17

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VYKOURALEUCOVORIN CALCIUMAvyxa Pharma, LLCd122b875-435e-4e00-b945-7a0546df95c22026-03-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 220406
application number: NDA220406
ndc (product): 83831-148

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
83831-148-35838310148351 VIAL, SINGLE-USE in 1 CARTON (83831-148-35) / 35 mL in 1 VIAL, SINGLE-USE2026-03-16NoNoCurrent