NDC 71881-109

PALFORZIA (Level 9)

Peanut

PALFORZIA (Level 9) is a Oral Powder in the Human Prescription Drug category. It is labeled and distributed by Aimmune Therapeutics. The primary component is Peanut.

• Product ID: 71881-109_9e94a32e-faed-4d5a-e053-2a95a90a72b1
• NDC: 71881-109
• Product Type: Human Prescription Drug
• Proprietary Name: PALFORZIA (Level 9)
• Generic Name: Peanut
• Dosage Form: Powder
• Route of Administration: ORAL
• Marketing Start Date: 2020-01-31
• Marketing Category: BLA / BLA
• Application Number: BLA125696
• Labeler Name: Aimmune Therapeutics
• Substance Name: PEANUT
• Active Ingredient Strength: 200 mg/1
• Pharm 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: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 71881-109-30

30 CAPSULE in 1 BLISTER PACK (71881-109-30) > 1 POWDER in 1 CAPSULE

• Marketing Start Date: 2020-01-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71881-109-99 [71881010999]

PALFORZIA (Level 9) POWDER

• Marketing Category: BLA
• Application Number: BLA125696
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-31

NDC 71881-109-09 [71881010909]

PALFORZIA (Level 9) POWDER

• Marketing Category: BLA
• Application Number: BLA125696
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-31

NDC 71881-109-30 [71881010930]

PALFORZIA (Level 9) POWDER

• Marketing Category: BLA
• Application Number: BLA125696
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PEANUT	200 mg/1

Pharmacological Class

• Non-Standardized Food Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Allergens [CS]
• Dietary Proteins [CS]
• Nut Proteins [EXT]

NDC Crossover Matching brand name "PALFORZIA (Level 9)" or generic name "Peanut"

NDC	Brand Name	Generic Name
71881-101	PALFORZIA	Peanut
71881-102	PALFORZIA	Peanut
71881-103	PALFORZIA	Peanut
71881-104	PALFORZIA	Peanut
71881-105	PALFORZIA	Peanut
71881-106	PALFORZIA	Peanut
71881-107	PALFORZIA	Peanut
71881-108	PALFORZIA	Peanut
71881-109	PALFORZIA	Peanut
71881-110	PALFORZIA	Peanut
71881-111	PALFORZIA	Peanut
71881-113	PALFORZIA	Peanut
0268-6193	PEANUT	PEANUT
36987-1550	Peanut	Peanut
36987-1551	Peanut	Peanut
36987-1552	Peanut	Peanut
36987-1553	Peanut	Peanut
49288-0379	Peanut	Peanut
54575-433	PEANUT FOOD	peanut