Search by Drug Name or NDC
NDC 57894-0503-01 Darzalex Faspro 1800; 30000 mg/15mL; U/15mL Details
Darzalex Faspro 1800; 30000 mg/15mL; U/15mL
Darzalex Faspro is a SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is DARATUMUMAB; HYALURONIDASE (HUMAN RECOMBINANT).
MedlinePlus Drug Summary
Daratumumab and hyaluronidase-fihj injection is used alone or in combination with other medications or treatments to treat multiple myeloma (a type of cancer of the bone marrow) in newly diagnosed people and in people who have not improved with treatment or who have improved after treatment with other medications but the condition returned. Daratumumab is also used in combination with other medications to treat a certain kind of amyloidosis (a disease in which abnormal proteins build up in tissues and organs in the body) in newly diagnosed adults. Daratumumab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Hyaluronidase-fihj is an endoglycosidase. It helps to keep daratumumab in the body longer so that the medication will have a greater effect.
Related Packages: 57894-0503-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Daratumumab and Hyaluronidase-fihj Injection
Product Information
| NDC | 57894-0503 |
|---|---|
| Product ID | 57894-503_0b3a8b34-5dd8-e8d8-e063-6294a90a980b |
| Associated GPIs | 21990002152020 |
| GCN Sequence Number | 080998 |
| GCN Sequence Number Description | daratumumab-hyaluronidase-fihj VIAL 1800-30000 SUBCUT |
| HIC3 | V3V |
| HIC3 Description | ANTINEOPLASTIC - ANTI-CD38 MONOCLONAL ANTIBODY |
| GCN | 47992 |
| HICL Sequence Number | 046509 |
| HICL Sequence Number Description | DARATUMUMAB-HYALURONIDASE-FIHJ |
| Brand/Generic | Brand |
| Proprietary Name | Darzalex Faspro |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | daratumumab and hyaluronidase-fihj (human recombinant) |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 1800; 30000 |
| Active Ingredient Units | mg/15mL; U/15mL |
| Substance Name | DARATUMUMAB; HYALURONIDASE (HUMAN RECOMBINANT) |
| Labeler Name | Janssen Biotech, Inc. |
| Pharmaceutical Class | Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC], Endoglycosidase [EPC], Glycoside Hydrolases [CS] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761145 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 57894-0503-01 (57894050301)
| NDC Package Code | 57894-503-01 |
|---|---|
| Billing NDC | 57894050301 |
| Package | 1 VIAL, SINGLE-DOSE in 1 BOX (57894-503-01) / 15 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2020-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |