plerixafor

Generic: plerixafor

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name plerixafor
Generic Name plerixafor
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

plerixafor 24 mg/1.2mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-155
Product ID 68083-155_db4c97b9-dee0-413d-ad28-e7190a956d0c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206644
Listing Expiration 2026-12-31
Marketing Start 2024-05-03

Pharmacologic Class

Established (EPC)
hematopoietic stem cell mobilizer [epc]
Physiologic Effect
increased hematopoietic stem cell mobilization [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083155
Hyphenated Format 68083-155

Supplemental Identifiers

RxCUI
828700
UNII
S915P5499N
NUI
N0000178326 N0000178324

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name plerixafor (source: ndc)
Generic Name plerixafor (source: ndc)
Application Number ANDA206644 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 24 mg/1.2mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-155-01) / 1.2 mL in 1 VIAL
source: ndc

Packages (1)

68083-155-01 1 VIAL in 1 CARTON (68083-155-01) / 1.2 mL in 1 VIAL

Ingredients (1)

plerixafor (24 mg/1.2mL)

Linked Drug Pages (1)

Plerixafor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "db4c97b9-dee0-413d-ad28-e7190a956d0c", "openfda": {"nui": ["N0000178326", "N0000178324"], "unii": ["S915P5499N"], "rxcui": ["828700"], "spl_set_id": ["fad65f5b-be13-4d3a-8df3-dace8e02708f"], "pharm_class_pe": ["Increased Hematopoietic Stem Cell Mobilization [PE]"], "pharm_class_epc": ["Hematopoietic Stem Cell Mobilizer [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-155-01)  / 1.2 mL in 1 VIAL", "package_ndc": "68083-155-01", "marketing_start_date": "20240503"}], "brand_name": "Plerixafor", "product_id": "68083-155_db4c97b9-dee0-413d-ad28-e7190a956d0c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Hematopoietic Stem Cell Mobilizer [EPC]", "Increased Hematopoietic Stem Cell Mobilization [PE]"], "product_ndc": "68083-155", "generic_name": "Plerixafor", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Plerixafor", "active_ingredients": [{"name": "PLERIXAFOR", "strength": "24 mg/1.2mL"}], "application_number": "ANDA206644", "marketing_category": "ANDA", "marketing_start_date": "20240503", "listing_expiration_date": "20261231"}