FDA.reportPublic FDA data

Litfulo

Product NDC
63539-334
11-digit product format
635390334
Labeler code
63539
Product ID
63539-334_5f5f631a-94b4-470e-939f-bbe09f204835
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ritlecitinib
Dosage form
CAPSULE
Route
ORAL
Labeler
U.S. Pharmaceuticals
Application
NDA215830
Marketing category
NDA
Marketing start
2023-07-06
Substance
RITLECITINIB TOSYLATE
Active strength
50 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Janus Kinase 3 Inhibitors [MoA], Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215830-001LITFULORITLECITINIB TOSYLATEEQ 50MG BASECAPSULE / ORALRLD, RS2023-06-23

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215830-001120775332034-12-03U-39942024-10-02
N215830-00196172582034-12-03Drug substance, Drug product2023-07-21
N215830-001121163682041-10-17Drug substance2024-10-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215830-001NCE2028-06-23

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
2026-08-01 22:54:322026-06N215830-001LITFULOEQ 50MG BASECAPSULE / ORALRLD, RS2023-06-23a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N215830-001120775332034-12-03U-39942024-10-02a50c72e98297…
2026-08-01 22:54:322026-06N215830-00196172582034-12-03Drug substance, Drug product2023-07-21a50c72e98297…
2026-08-01 22:54:322026-06N215830-001121163682041-10-17Drug substance2024-10-17a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N215830-001NCE2028-06-23a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LitfuloRITLECITINIBU.S. Pharmaceuticals1882f799-61b0-4813-965a-4910c4ae419c2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 215830
application number: NDA215830
ndc (product): 63539-334
LitfuloRITLECITINIBPfizer Laboratories Div Pfizer Inc6b2f9446-fb23-4741-b73a-5a2f993733c32026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 215830
application number: NDA215830

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RITLECITINIB TOSYLATE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EAG4T1459KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2641601Internal RxNorm lookup
2641607Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1882f799-61b0-4813-965a-4910c4ae419cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4f034d61-108f-45bd-ade2-f2d536b61b7cProduct name120231023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63539-334-28Litfulo28 in 1 BOTTLECAPSULE282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63539-334LITFULO (RITLECITINIB) CAPSULE [U.S. PHARMACEUTICALS]2Current NDC, 1 package rows20250322_1882f799-61b0-4813-965a-4910c4ae419c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2641607Litfulo 50 MG Oral CapsulePSN1882f799-61b0-4813-965a-4910c4ae419c2
2641601ritlecitinib 50 MG Oral CapsulePSN1882f799-61b0-4813-965a-4910c4ae419c2
2641607ritlecitinib 50 MG Oral Capsule [Litfulo]SBD1882f799-61b0-4813-965a-4910c4ae419c2
2641601ritlecitinib 50 MG Oral CapsuleSCD1882f799-61b0-4813-965a-4910c4ae419c2
2641607Litfulo 50 MG (equivalent to ritlecitinib tosylate 80.13 MG) Oral CapsuleSY1882f799-61b0-4813-965a-4910c4ae419c2
2641601ritlecitinib 50 MG (equivalent to ritlecitinib tosylate 80.13 MG) Oral CapsuleSY1882f799-61b0-4813-965a-4910c4ae419c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63539-334-286353903342828 CAPSULE in 1 BOTTLE (63539-334-28) 28 capsule2023-07-06YesNoCurrent