PALFORZIA

Product NDC
71881-106
11-digit product format
718810106
Labeler code
71881
Product ID
71881-106_bd4af136-f806-e5c8-e053-2a95a90a8c2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Peanut
Dosage form
POWDER
Route
ORAL
Labeler
Aimmune Therapeutics
Application
BLA125696
Marketing category
BLA
Marketing start
2020-01-31
Marketing end
0000-00-00
Substance
PEANUT
Active strength
80 mg/1
Pharmacologic classes
Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71881-106DDiscontinued by firm2026-08-10
excluded packagepackage71881-10671881-106-60DDiscontinued by firm2026-08-10
excluded packagepackage71881-10671881-106-99DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71881-106-60IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71881-106-99IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71881-106-60IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71881-106-99IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71881-106-60IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71881-106-99IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71881-106-60IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71881-106-99IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71881-106-60IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71881-106-99IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71881-106-60IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71881-106-99IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71881-106-99UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71881-106-60UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71881-106-99UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71881-106-60UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71881-106-99UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71881-106-60UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71881-106-602025-01-30These highlights do not include all the information needed to use PALFORZIA safely and effectively. See Full Prescribing Information for PALFORZIA. PALFORZIA [Peanut ( Arachis hypogaea ) Allergen Powder-dnfp] Powder for oral administration Initial U.S. Approval: 2020
71881-106-992025-01-30These highlights do not include all the information needed to use PALFORZIA safely and effectively. See Full Prescribing Information for PALFORZIA. PALFORZIA [Peanut ( Arachis hypogaea ) Allergen Powder-dnfp] Powder for oral administration Initial U.S. Approval: 2020
71881-106-602023-02-07These highlights do not include all the information needed to use PALFORZIA safely and effectively. See Full Prescribing Information for PALFORZIA. PALFORZIA [Peanut ( Arachis hypogaea ) Allergen Powder-dnfp] Powder for oral administration Initial U.S. Approval: 2020
71881-106-992023-02-07These highlights do not include all the information needed to use PALFORZIA safely and effectively. See Full Prescribing Information for PALFORZIA. PALFORZIA [Peanut ( Arachis hypogaea ) Allergen Powder-dnfp] Powder for oral administration Initial U.S. Approval: 2020
71881-106-602023-01-30These highlights do not include all the information needed to use PALFORZIA safely and effectively. See Full Prescribing Information for PALFORZIA. PALFORZIA [Peanut ( Arachis hypogaea ) Allergen Powder-dnfp] Powder for oral administration Initial U.S. Approval: 2020
71881-106-992023-01-30These highlights do not include all the information needed to use PALFORZIA safely and effectively. See Full Prescribing Information for PALFORZIA. PALFORZIA [Peanut ( Arachis hypogaea ) Allergen Powder-dnfp] Powder for oral administration Initial U.S. Approval: 2020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71881-106-60EA - Each71881-106a0e11812-9d6c-41e4-ae62-fd853093b27e12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71881-106PALFORZIA INITIAL DOSE ESCALATION (PEANUT) KIT PALFORZIA (LEVEL 1) (PEANUT) POWDER PALFORZIA (LEVEL 2) (PEANUT) POWDER PALFORZIA (LEVEL 3) (PEANUT) KIT PALFORZIA (LEVEL 4) (PEANUT) POWDER PALFORZIA (LEVEL 5) (PEANUT) POWDER PALFORZIA (LEVEL 6) (PEANUT) POWDER PALFORZIA (LEVEL 7) (PEANUT) KIT PALFORZIA (LEVEL 8) (PEANUT) KIT PALFORZIA (LEVEL 9) (PEANUT) POWDER PALFORZIA (LEVEL 10) (PEANUT) KIT PALFORZIA (LEVEL 11) (PEANUT) POWDER [AIMMUNE THERAPEUTICS]6Legacy NDC20230320_17f5be03-6705-4ac9-b8f3-bc4993ebc0eb.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125696PalforziaPeanut (Arachis hypogaea) Allergen Powder-dnfp351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71881-106-607188101066060 CAPSULE in 1 BLISTER PACK (71881-106-60) > 1 POWDER in 1 CAPSULE60 capsule2020-01-310000-00-00NoNoCurrent
71881-106-997188101069912 BLISTER PACK in 1 CARTON (71881-106-99) > 4 CAPSULE in 1 BLISTER PACK (71881-106-09) > 1 POWDER in 1 CAPSULE12 blister pack2020-01-310000-00-00YesNoCurrent