Prescription drug · BLA
Elahere (Mirvetuximab soravtansine) NDC 72903-853
Mirvetuximab soravtansine 5 mg/mL · Injection, Solution · Intravenous · ImmunoGen, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72903-853-01 | 72903085301 | 1 VIAL, SINGLE-USE in 1 CARTON (72903-853-01) / 20 mL in 1 VIAL, SINGLE-USEMarketed from Nov 14, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Elahere
- Generic name (nonproprietary)
- mirvetuximab soravtansine
- Active ingredients
- Mirvetuximab soravtansine — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- ImmunoGen, Inc.NDC labeler code 72903
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761310
- Marketing start
- Listing expires
- Identifiers
- Product ID 72903-853_47f1c78d-c469-4cd7-926e-51ce5b2d26f5SPL ID 47f1c78d-c469-4cd7-926e-51ce5b2d26f5SPL set ID 00c424b5-6ccd-48ab-9e88-1986451120e2RxCUI 2621553, 2621559UNII 98DE7VN88D
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N472903085301followed by a unit qualifier and the quantityPackage 72903-0853-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
ELAHERE ® is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test [see Dosage and Administration ( 2.1 )]. ELAHERE is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on …
Excerpt only. Read the full label for complete information.
About NDC 72903-853
- What is NDC 72903-853?
- 72903-853 is the product NDC for Elahere (mirvetuximab soravtansine), Mirvetuximab soravtansine 5 mg/mL injection, solution, listed with the FDA by ImmunoGen, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Elahere (Mirvetuximab soravtansine).
- What is the active ingredient?
- Mirvetuximab soravtansine.
- Who is the labeler?
- ImmunoGen, Inc., NDC labeler code 72903. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Elahere?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.