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NDC 71881-0101-99 PALFORZIA 3 mg/1 Details
PALFORZIA 3 mg/1
PALFORZIA is a ORAL POWDER in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aimmune Therapeutics. The primary component is PEANUT.
Product Information
| NDC | 71881-0101 |
|---|---|
| Product ID | 71881-101_f724158a-5c2e-fa1e-e053-6394a90a5519 |
| Associated GPIs | 2010004020H525 |
| GCN Sequence Number | 080694 |
| GCN Sequence Number Description | peanut allergen powder-dnfp CAP SPRINK 3 MG ORAL |
| HIC3 | W7W |
| HIC3 Description | ALLERGENIC EXTRACTS, THERAPEUTIC |
| GCN | 47647 |
| HICL Sequence Number | 046332 |
| HICL Sequence Number Description | PEANUT ALLERGEN POWDER-DNFP |
| Brand/Generic | Brand |
| Proprietary Name | PALFORZIA |
| Proprietary Name Suffix | (Level 1) |
| Non-Proprietary Name | Peanut |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER |
| Route | ORAL |
| Active Ingredient Strength | 3 |
| Active Ingredient Units | mg/1 |
| Substance Name | PEANUT |
| Labeler Name | Aimmune Therapeutics |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Nut Proteins [EXT] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125696 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71881-0101-99 (71881010199)
| NDC Package Code | 71881-101-99 |
|---|---|
| Billing NDC | 71881010199 |
| Package | 18 BLISTER PACK in 1 CARTON (71881-101-99) / 3 CAPSULE in 1 BLISTER PACK (71881-101-09) / 1 POWDER in 1 CAPSULE |
| Marketing Start Date | 2020-01-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |