Home NDC 70710-1208 PLERIXAFOR
Product NDC 70710-1208
11-digit product format 707101208
Labeler code 70710
Product ID 70710-1208_6eded16b-f43d-4984-bd7c-33ca6d5e3195
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name plerixafor
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA208980
Marketing category ANDA
Marketing start 2023-07-28
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 A208980-001 PLERIXAFOR PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26
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 2026-02-19 14:30 UTC 2026-02 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-07-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-07-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-07-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS AP 2023-07-26 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208980-001 PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION / SUBCUTANEOUS 2023-07-26 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 70710-1208-1 PLERIXAFOR 1.2 mL in 1 VIAL, SINGLE-USE INJECTION 1.2 3 70710-1208-1 PLERIXAFOR 1 in 1 CARTON INJECTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1208 PLERIXAFOR INJECTION [ZYDUS PHARMACEUTICALS USA INC.] 3 Current NDC, 2 package rows 20241208_a0a058f9-1618-4853-9b8a-e9768ee86b39.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 70710-1208-1 70710120801 1 VIAL, SINGLE-USE in 1 CARTON (70710-1208-1) / 1.2 mL in 1 VIAL, SINGLE-USE 2023-07-28 No No Current