Home NDC 83296-100 XOLREMDI
Product NDC 83296-100
11-digit product format 832960100
Labeler code 83296
Product ID 83296-100_26bdd232-8068-9080-e063-6394a90aa084
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mavorixafor
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler X4 Pharmaceuticals, Inc.
Application NDA218709
Marketing category NDA
Marketing start 2024-05-21
Substance MAVORIXAFOR
Active strength 100 mg/1
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 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 N218709-001 XOLREMDI MAVORIXAFOR 100MG CAPSULE / ORAL RLD, RS 2024-04-26
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218709-001 10953003 2036-12-14 Drug product 2024-05-24 N218709-001 10610527 2036-12-22 U-3932 2024-05-24 N218709-001 11219621 2036-12-22 U-3932 2024-05-24 N218709-001 10548889 2038-12-11 Drug product 2024-05-24 N218709-001 11045461 2038-12-11 Drug product 2024-05-24 N218709-001 12115156 2038-12-11 Drug product 2024-10-31
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N218709-001 NCE 2029-04-26 N218709-001 ODE-480 2031-04-26
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 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218709-001 XOLREMDI 100MG CAPSULE / ORAL RLD, RS 2024-04-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 91 observed states.
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 N218709-001 10953003 2036-12-14 Drug product 2024-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218709-001 10610527 2036-12-22 U-3932 2024-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218709-001 11219621 2036-12-22 U-3932 2024-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218709-001 10548889 2038-12-11 Drug product 2024-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218709-001 11045461 2038-12-11 Drug product 2024-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218709-001 12115156 2038-12-11 Drug product 2024-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218709-001 10953003 2036-12-14 Drug product 2024-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218709-001 10610527 2036-12-22 U-3932 2024-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218709-001 11219621 2036-12-22 U-3932 2024-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218709-001 10548889 2038-12-11 Drug product 2024-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218709-001 11045461 2038-12-11 Drug product 2024-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218709-001 12115156 2038-12-11 Drug product 2024-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218709-001 10953003 2036-12-14 Drug product 2024-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218709-001 10610527 2036-12-22 U-3932 2024-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218709-001 11219621 2036-12-22 U-3932 2024-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218709-001 10548889 2038-12-11 Drug product 2024-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218709-001 11045461 2038-12-11 Drug product 2024-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218709-001 12115156 2038-12-11 Drug product 2024-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218709-001 10953003 2036-12-14 Drug product 2024-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218709-001 10610527 2036-12-22 U-3932 2024-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218709-001 11219621 2036-12-22 U-3932 2024-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218709-001 10548889 2038-12-11 Drug product 2024-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218709-001 11045461 2038-12-11 Drug product 2024-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218709-001 12115156 2038-12-11 Drug product 2024-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218709-001 10953003 2036-12-14 Drug product 2024-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218709-001 10610527 2036-12-22 U-3932 2024-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218709-001 11219621 2036-12-22 U-3932 2024-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218709-001 10548889 2038-12-11 Drug product 2024-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218709-001 11045461 2038-12-11 Drug product 2024-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218709-001 12115156 2038-12-11 Drug product 2024-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218709-001 10953003 2036-12-14 Drug product 2024-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218709-001 10610527 2036-12-22 U-3932 2024-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218709-001 11219621 2036-12-22 U-3932 2024-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218709-001 10548889 2038-12-11 Drug product 2024-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218709-001 11045461 2038-12-11 Drug product 2024-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218709-001 12115156 2038-12-11 Drug product 2024-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218709-001 10953003 2036-12-14 Drug product 2024-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218709-001 10610527 2036-12-22 U-3932 2024-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218709-001 11219621 2036-12-22 U-3932 2024-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218709-001 10548889 2038-12-11 Drug product 2024-05-24 b8a1b40f171c…
Observed Orange Book exclusivity history# 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 XOLREMDI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAVORIXAFOR 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0G9LGB5O2W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2684026 Internal RxNorm lookup 2684032 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 83296-100-12 XOLREMDI 120 in 1 BOTTLE CAPSULE, GELATIN COATED 120 7 83296-100-60 XOLREMDI 60 in 1 BOTTLE CAPSULE, GELATIN COATED 60 7 83296-100-90 XOLREMDI 90 in 1 BOTTLE CAPSULE, GELATIN COATED 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83296-100 XOLREMDI (MAVORIXAFOR) CAPSULE, GELATIN COATED [X4 PHARMACEUTICALS, INC.] 7 Current NDC, 3 package rows 20241116_7f3a5ee3-ca73-4876-85a0-ed1e108a2237.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 · 1 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 83296-100-12 83296010012 120 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-12) 2024-05-21 No No Current 83296-100-60 83296010060 60 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-60) 2024-05-21 No No Current 83296-100-90 83296010090 90 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-90) 2024-11-01 No No Current