Prescription drug · NDA
Forzinity (Elamipretide hydrochloride) NDC 72507-800
Elamipretide hydrochloride 280 mg/3.5mL · Injection · Subcutaneous · Stealth Biotherapeutics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72507-800-04 | 72507080004 | 4 VIAL in 1 CARTON (72507-800-04) / 3.5 mL in 1 VIAL (72507-800-30)Marketed from Oct 30, 2025 |
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)
- Forzinity
- Generic name (nonproprietary)
- elamipretide hydrochloride
- Active ingredients
- Elamipretide hydrochloride — 280 mg/3.5mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Stealth Biotherapeutics Inc.NDC labeler code 72507
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215244
- Marketing start
- Listing expires
- Identifiers
- Product ID 72507-800_459e2433-fbbb-2cef-e063-6394a90a81fdSPL ID 459e2433-fbbb-2cef-e063-6394a90a81fdSPL set ID 146bf34c-76f2-48db-ac07-fb29cce2cd75RxCUI 2725604, 2725610UNII E40WZ3BK2D
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
N472507080004followed by a unit qualifier and the quantityPackage 72507-0800-04. 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 .
Indications (excerpt from the label)
FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. FORZINITY™ is a mitochondrial cardiolipin binder indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. ( 1 ) This indication is approved under accelerated approval based on an improvement in knee ext…
Excerpt only. Read the full label for complete information.
About NDC 72507-800
- What is NDC 72507-800?
- 72507-800 is the product NDC for Forzinity (elamipretide hydrochloride), Elamipretide hydrochloride 280 mg/3.5mL injection, listed with the FDA by Stealth Biotherapeutics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Forzinity (Elamipretide Hydrochloride).
- What is the active ingredient?
- Elamipretide hydrochloride.
- Who is the labeler?
- Stealth Biotherapeutics Inc., NDC labeler code 72507. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Forzinity?
- 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.