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NDC 71274-0170-60 Joenja 70 mg/1 Details
Joenja 70 mg/1
Joenja is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Pharming Healthcare Inc.. The primary component is LENIOLISIB PHOSPHATE.
MedlinePlus Drug Summary
Leniolisib is used to treat adults and children 12 years of age and older who have activated phosphoinositide 3-kinase delta syndrome (APDS; an genetic condition that decreases the activity of the immune system and can result in recurrent infections, swollen lymph nodes and spleen, and a certain type of lymphoma [a type of blood cancer]). Leniolisib is in a class of medications called kinase inhibitors. It works by blocking the signals that cause abnormalities in the immune system, which improves the functions of the immune system.
Related Packages: 71274-0170-60Last Updated: 05/12/2024
MedLinePlus Full Drug Details: Leniolisib
Product Information
| NDC | 71274-0170 |
|---|---|
| Product ID | 71274-170_7cfc3968-6a21-4c48-b72c-01ee71b7e6cf |
| Associated GPIs | |
| GCN Sequence Number | 084559 |
| GCN Sequence Number Description | leniolisib phosphate TABLET 70 MG ORAL |
| HIC3 | Z2H |
| HIC3 Description | SYSTEMIC ENZYME INHIBITORS |
| GCN | 53895 |
| HICL Sequence Number | 048803 |
| HICL Sequence Number Description | LENIOLISIB PHOSPHATE |
| Brand/Generic | Brand |
| Proprietary Name | Joenja |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Leniolisib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 70 |
| Active Ingredient Units | mg/1 |
| Substance Name | LENIOLISIB PHOSPHATE |
| Labeler Name | Pharming Healthcare Inc. |
| Pharmaceutical Class | Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Kinase Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Phosphoinositide 3-K |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA217759 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71274-0170-60 (71274017060)
| NDC Package Code | 71274-170-60 |
|---|---|
| Billing NDC | 71274017060 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (71274-170-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2023-03-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |