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NDC 00069-0334-28 Litfulo 50 mg/1 Details
Litfulo 50 mg/1
Litfulo is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is RITLECITINIB TOSYLATE.
Product Information
| NDC | 00069-0334 |
|---|---|
| Product ID | 0069-0334_4de417fe-fb93-4b56-84bc-20763a43b323 |
| Associated GPIs | |
| GCN Sequence Number | 084997 |
| GCN Sequence Number Description | ritlecitinib tosylate CAPSULE 50 MG ORAL |
| HIC3 | Z2Z |
| HIC3 Description | JANUS KINASE (JAK) INHIBITORS |
| GCN | 54429 |
| HICL Sequence Number | 049026 |
| HICL Sequence Number Description | RITLECITINIB TOSYLATE |
| Brand/Generic | Brand |
| Proprietary Name | Litfulo |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ritlecitinib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | RITLECITINIB TOSYLATE |
| Labeler Name | Pfizer Laboratories Div Pfizer Inc |
| Pharmaceutical Class | Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Janus Kinase 3 Inhibitors [MoA], Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA215830 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00069-0334-28 (00069033428)
| NDC Package Code | 0069-0334-28 |
|---|---|
| Billing NDC | 00069033428 |
| Package | 28 CAPSULE in 1 BOTTLE (0069-0334-28) |
| Marketing Start Date | 2023-07-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |