PLERIXAFOR- plerixafor injection 
Zydus Lifesciences Limited

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PLERIXAFOR injection, for subcutaneous use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1776-1

Plerixafor Injection – 1.2 mL vial label

24 mg/1.2 mL

(20 mg/mL)

For subcutaneous injection only

For single-dose only

Rx only

vial label

NDC 70771-1776-1

Carton contains one vial of

Plerixafor Injection

24 mg/1.2 mL

(20 mg/mL)

For subcutaneous injection only

See package insert for dosage and administration

For single-dose only

Rx only

carton label
PLERIXAFOR 
plerixafor injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1776
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PLERIXAFOR (UNII: S915P5499N) (PLERIXAFOR - UNII:S915P5499N) PLERIXAFOR24 mg  in 1.2 mL
Inactive Ingredients
Ingredient NameStrength
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM CHLORIDE (UNII: 451W47IQ8X) 5.9 mg  in 1.2 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1776-11 in 1 CARTON07/28/2023
11.2 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20898007/28/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650348852MANUFACTURE(70771-1776) , ANALYSIS(70771-1776)

Revised: 7/2023
Document Id: 41b76e97-b780-4fc8-b073-13bf155ad8a5
Set id: 43df348a-d7f2-4f14-8131-c916679a98eb
Version: 1
Effective Time: 20230728
 
Zydus Lifesciences Limited