Home NDC 73441-062 APHEXDA
Product NDC 73441-062
11-digit product format 734410062
Labeler code 73441
Product ID 73441-062_876ecb7b-a6d5-442b-a5a1-4e24203853cc
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 43 .
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 2026-09-14 22:38:34 2026-08 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217159-001 APHEXDA EQ 62MG BASE/VIAL POWDER / SUBCUTANEOUS RLD, RS 2023-09-08 caaa826d4ba7…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 2026-09-14 22:38:34 2026-08 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217159-001 12268725 2041-12-29 Drug product 2025-04-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217159-001 12257285 2041-12-29 Drug product 2025-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217159-001 12268725 2041-12-29 Drug product 2025-04-10 caaa826d4ba7…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# Exclusivity history page 1 of 2 · 42 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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 · 2 matching rows.
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