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 2026-02-19 14:30 UTC 2026-02 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 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 2026-02-19 14:30 UTC 2026-02 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217159-001 12268725 2041-12-29 Drug product 2025-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217159-001 12268725 2041-12-29 Drug product 2025-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217159-001 12268725 2041-12-29 Drug product 2025-04-10 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217159-001 12268725 2041-12-29 Drug product 2025-04-10 a50c72e98297…
Observed Orange Book exclusivity history# 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