PLERIXAFOR injection, for subcutaneous use

Manufacturer: Zydus Lifesciences Limited
Effective date: 2023-07-28
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:51:50

Label at a glance#

ProductPLERIXAFOR

Active ingredientPLERIXAFOR

Label structure1 sections

Label contents#

Full prescribing information#

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

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
828700	plerixafor 24 MG in 1.2 ML Injection	PSN	1
828700	1.2 ML plerixafor 20 MG/ML Injection	SCD	1
828700	plerixafor 24 MG per 1.2 ML Injection	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PLERIXAFOR Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	DataBar Omni	(01)00370771177615	GTIN-14: 00370771177615 GTIN-12: 370771177615 UPC-A: 370771177615 EAN-13: 0370771177615 GTIN storage (14 digits): 00370771177615	41b76e97-b780-4fc8-b073-13bf155ad8a5-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e9e3bcdc-866b-12bf-8547-f275901d8135	Product name	2	20240828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70771-1776-1	PLERIXAFOR	1.2 mL in 1 VIAL, SINGLE-USE	INJECTION	1.2		1
70771-1776-1	PLERIXAFOR	1 in 1 CARTON	INJECTION	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1776	PLERIXAFOR INJECTION [ZYDUS LIFESCIENCES LIMITED]	1	Current NDC, 2 package rows	20230728_43df348a-d7f2-4f14-8131-c916679a98eb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

PLERIXAFOR
HYDROCHLORIC ACID
SODIUM CHLORIDE
SODIUM HYDROXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1776	70771-1776-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PLERIXAFOR	S915P5499N	ACTIB
HYDROCHLORIC ACID	QTT17582CB	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A208980-001	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION / SUBCUTANEOUS		2023-07-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208980-001	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION / SUBCUTANEOUS		2023-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208980-001	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION / SUBCUTANEOUS		2023-07-26	`caaa826d4ba7…`
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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A208980-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208980-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208980-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208980-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208980-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208980-001	AP	1	`9b2671bbb829…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PLERIXAFOR	PLERIXAFOR	Zydus Lifesciences Limited	43df348a-d7f2-4f14-8131-c916679a98eb	2023-07-28		Exact identifier ndc (package): 70771-1776-1 ndc (product): 70771-1776 ndc11 (package): 70771177601 spl id: 41b76e97-b780-4fc8-b073-13bf155ad8a5 spl set id: 43df348a-d7f2-4f14-8131-c916679a98eb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.