FDA.reportPublic FDA data

APHEXDA

Product NDC
73441-062
11-digit product format
734410062
Labeler code
73441
Product ID
73441-062_799be625-4029-451b-85f8-dc430ffb2dd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MOTIXAFORTIDE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
SUBCUTANEOUS
Labeler
Gamida Cell Inc.
Application
NDA217159
Marketing category
NDA
Marketing start
2025-06-15
Substance
MOTIXAFORTIDE ACETATE
Active strength
62 mg/1.7mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217159-001APHEXDAMOTIXAFORTIDE ACETATEEQ 62MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2023-09-08

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217159-001122572852041-12-29Drug product2025-04-10
N217159-001122687252041-12-29Drug product2025-04-10

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217159-001NCE2028-09-08
N217159-001ODE-4422030-09-08

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 22:54:322026-06N217159-001APHEXDAEQ 62MG BASE/VIALPOWDER / SUBCUTANEOUSRLD, RS2023-09-08a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N217159-001122572852041-12-29Drug product2025-04-10a50c72e98297…
2026-08-01 22:54:322026-06N217159-001122687252041-12-29Drug product2025-04-10a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N217159-001NCE2028-09-08a50c72e98297…
2026-08-01 22:54:322026-06N217159-001ODE-4422030-09-08a50c72e98297…

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
APHEXDAMOTIXAFORTIDEGamida Cell Inc.e704b2db-f119-40ba-9346-9229e3281c9e2026-06-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 217159
application number: NDA217159
ndc (product): 73441-062
AphexdaMOTIXAFORTIDEBioLineRx USA Incf7cdc584-ebf0-a68e-e053-6294a90a9ea92024-10-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 217159
application number: NDA217159

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOTIXAFORTIDE ACETATE62 mg/1.7mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ZPX60DV8AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2664901Internal RxNorm lookup
2664906Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e704b2db-f119-40ba-9346-9229e3281c9eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5a889d15-70b1-4eae-8941-15899f444e0dProduct name120231013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73441-062-01APHEXDA1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14
73441-062-01APHEXDA1.7 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,1.74

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73441-062-01EA - Each73441-0623b2513b7-b938-44dd-aa96-515e5deffd2912025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2664906APHEXDA 62 MG InjectionPSNe704b2db-f119-40ba-9346-9229e3281c9e4
2664901motixafortide 62 MG InjectionPSNe704b2db-f119-40ba-9346-9229e3281c9e4
2664906motixafortide 62 MG Injection [Aphexda]SBDe704b2db-f119-40ba-9346-9229e3281c9e4
2664901motixafortide 62 MG InjectionSCDe704b2db-f119-40ba-9346-9229e3281c9e4
2664906Aphexda 62 MG (as motixafortide acetate) InjectionSYe704b2db-f119-40ba-9346-9229e3281c9e4
2664906Aphexda 62 MG InjectionSYe704b2db-f119-40ba-9346-9229e3281c9e4
2664901motixafortide 62 MG (as motixafortide acetate) InjectionSYe704b2db-f119-40ba-9346-9229e3281c9e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73441-062-01734410062011 VIAL, GLASS in 1 CARTON (73441-062-01) / 1.7 mL in 1 VIAL, GLASS2025-06-15NoNoCurrent