Home NDC 82737-073 Aphexda
Product NDC 82737-073
11-digit product format 827370073
Labeler code 82737
Product ID 82737-073_241b0b4f-eca3-be93-e063-6394a90a5789
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Motixafortide
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route SUBCUTANEOUS
Labeler BioLineRx USA Inc
Application NDA217159
Marketing category NDA
Marketing start 2023-09-08
Substance MOTIXAFORTIDE ACETATE
Active strength 62 mg/1.7mL
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-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# Additional Listing Data#
Finished product Yes
Brand name base Aphexda
Listing expiration 2026-12-31 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 82737-073-01 Aphexda 1.7 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 1.7 2 82737-073-01 Aphexda 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82737-073 APHEXDA (MOTIXAFORTIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BIOLINERX USA INC] 2 Current NDC, 2 package rows 20241011_f7cdc584-ebf0-a68e-e053-6294a90a9ea9.zip
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 82737-073-01 82737007301 1 VIAL, GLASS in 1 CARTON (82737-073-01) / 1.7 mL in 1 VIAL, GLASS 2023-09-08 No No Current