FDA.reportPublic FDA data

Plerixafor

Product NDC
31722-373
11-digit product format
317220373
Labeler code
31722
Product ID
31722-373_447a1ba3-4d5e-f506-e063-6394a90aab72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Plerixafor
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA217560
Marketing category
ANDA
Marketing start
2025-06-16
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217560-001PLERIXAFORPLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2025-06-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217560-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217560-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2025-06-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217560-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2025-06-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A217560-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2025-06-166a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217560-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2025-06-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217560-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217560-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217560-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217560-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Plerixafor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PLERIXAFOR24 mg/1.2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S915P5499NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
828700Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb8e1167-8378-4e73-9bcb-d69093ec829bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e9e3bcdc-866b-12bf-8547-f275901d8135Product name220240828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-373-31Plerixafor1.2 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION1.21
31722-373-31Plerixafor1 in 1 CARTONINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-373-31ML - Milliliter31722-373ef591c42-b7b4-457b-a028-24ffac710ecd12026-03-17

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PlerixaforPLERIXAFORCamber Pharmaceuticals, Inc.bb8e1167-8378-4e73-9bcb-d69093ec829b2025-11-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217560
application number: ANDA217560
ndc (product): 31722-373

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828700plerixafor 24 MG in 1.2 ML InjectionPSNbb8e1167-8378-4e73-9bcb-d69093ec829b1
8287001.2 ML plerixafor 20 MG/ML InjectionSCDbb8e1167-8378-4e73-9bcb-d69093ec829b1
828700plerixafor 24 MG per 1.2 ML InjectionSYbb8e1167-8378-4e73-9bcb-d69093ec829b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-373-31317220373311 VIAL, SINGLE-USE in 1 CARTON (31722-373-31) / 1.2 mL in 1 VIAL, SINGLE-USE2025-06-16NoNoCurrent