Home NDC 65219-284 Plerixafor
Product NDC 65219-284
11-digit product format 652190284
Labeler code 65219
Product ID 65219-284_ba468eca-fb47-497b-8aed-a1576249ea6a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PLERIXAFOR
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Fresenius Kabi Usa, LLC
Application NDA022311
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2023-06-22
Substance PLERIXAFOR
Active strength 24 mg/1.2mL
Pharmacologic classes Hematopoietic Stem Cell Mobilizer [EPC], Increased Hematopoietic Stem Cell Mobilization [PE]
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 N022311-001 MOZOBIL PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022311-001 AP
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.
Product history page 1 of 2 · 41 observed 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 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP RLD, RS 2008-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022311-001 MOZOBIL 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2008-12-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Plerixafor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PLERIXAFOR 24 mg/1.2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S915P5499N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 828700 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 65219-284-12 Plerixafor 1.2 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 1.2 12 65219-284-12 Plerixafor 1 in 1 CARTON INJECTION, SOLUTION 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-284 PLERIXAFOR INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 11 Current NDC, 2 package rows 20231012_5d670cb4-163e-498c-b5fa-c193ea9d55c0.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 65219-284-12 65219028412 1 VIAL, SINGLE-USE in 1 CARTON (65219-284-12) / 1.2 mL in 1 VIAL, SINGLE-USE 2023-06-22 No No Current