Home NDC 73441-062 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217159-001 APHEXDA MOTIXAFORTIDE ACETATE EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217159-001 12257285 2041-12-29 Drug product 2025-04-10 N217159-001 12268725 2041-12-29 Drug product 2025-04-10
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217159-001 NCE 2028-09-08 N217159-001 ODE-442 2030-09-08
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N217159-001 12268725 2041-12-29 Drug product 2025-04-10 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N217159-001 NCE 2028-09-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N217159-001 ODE-442 2030-09-08 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base APHEXDA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOTIXAFORTIDE ACETATE 62 mg/1.7mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3ZPX60DV8A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2664901 Internal RxNorm lookup 2664906 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73441-062-01 APHEXDA 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4 73441-062-01 APHEXDA 1.7 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 1.7 4
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 73441-062-01 73441006201 1 VIAL, GLASS in 1 CARTON (73441-062-01) / 1.7 mL in 1 VIAL, GLASS 2025-06-15 No No Current