Home NDC 68083-155 Plerixafor
Product NDC 68083-155
11-digit product format 680830155
Labeler code 68083
Product ID 68083-155_db4c97b9-dee0-413d-ad28-e7190a956d0c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Plerixafor
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Gland Pharma Limited
Application ANDA206644
Marketing category ANDA
Marketing start 2024-05-03
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 A206644-001 PLERIXAFOR PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206644-001 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.
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 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206644-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2024-05-03 a50c72e98297…
Observed Orange Book normalized TE history# 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 68083-155-01 Plerixafor 1 in 1 CARTON INJECTION, SOLUTION 1 6 68083-155-01 Plerixafor 1.2 mL in 1 VIAL INJECTION, SOLUTION 1.2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-155 PLERIXAFOR INJECTION, SOLUTION [GLAND PHARMA LIMITED] 6 Current NDC, 2 package rows 20240509_fad65f5b-be13-4d3a-8df3-dace8e02708f.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 Units Marketing start Sample Exclude flag Status 68083-155-01 68083015501 1 VIAL in 1 CARTON (68083-155-01) / 1.2 mL in 1 VIAL 1 vial 2024-05-03 No No Current