Plerixafor

Product NDC
72162-2642
11-digit product format
721622642
Labeler code
72162
Product ID
72162-2642_02d8fd34-6323-4bc3-b0eb-df427b1de6cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Plerixafor
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Bryant Ranch Prepack
Application
ANDA211901
Marketing category
ANDA
Marketing start
2023-07-25
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
2027-12-31
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
A211901-001PLERIXAFORPLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211901-001AP

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 UTC2026-02A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-248072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-249b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211901-001PLERIXAFOR24MG/1.2ML (20MG/ML)SOLUTION / SUBCUTANEOUSAP2023-07-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211901-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211901-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211901-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211901-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211901-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211901-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211901-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211901-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211901-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211901-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211901-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211901-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211901-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211901-001AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211901-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211901-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211901-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211901-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211901-001AP19b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211901-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Plerixafor
Listing expiration
2027-12-31

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
b42fda2a-80c8-4bdd-a91d-03d11bef064aAvailable 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
72162-2642-2Plerixafor1 in 1 CARTONINJECTION, SOLUTION1100
72162-2642-2Plerixafor1.2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1.2100

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PlerixaforPLERIXAFORBryant Ranch Prepackb42fda2a-80c8-4bdd-a91d-03d11bef064a2026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211901
application number: ANDA211901
ndc (product): 72162-2642
PlerixaforPLERIXAFORNovadoz Pharmaceuticals LLCf26effc5-2a22-441f-91ac-e131ee1c98862024-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211901
application number: ANDA211901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828700plerixafor 24 MG in 1.2 ML InjectionPSNb42fda2a-80c8-4bdd-a91d-03d11bef064a100
8287001.2 ML plerixafor 20 MG/ML InjectionSCDb42fda2a-80c8-4bdd-a91d-03d11bef064a100
828700plerixafor 24 MG per 1.2 ML InjectionSYb42fda2a-80c8-4bdd-a91d-03d11bef064a100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2642-2721622642021 VIAL, SINGLE-DOSE in 1 CARTON (72162-2642-2) / 1.2 mL in 1 VIAL, SINGLE-DOSE2026-05-06NoNoCurrent