Prescription drug · BLA
Pasatru (Garetosmab-grts) NDC 61755-012
Garetosmab 300 mg/5mL · Injection, Solution, Concentrate · Intravenous · Regeneron Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61755-012-01 | 61755001201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-012-01) / 5 mL in 1 VIAL, SINGLE-DOSE (61755-012-00)Marketed from Aug 19, 2026 |
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)
- Pasatru
- Generic name (nonproprietary)
- garetosmab-grts
- Active ingredients
- Garetosmab — 300 mg/5mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Regeneron Pharmaceuticals, Inc.NDC labeler code 61755
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761508
- Marketing start
- Listing expires
- Identifiers
- Product ID 61755-012_aa61176b-8199-47b9-ae53-66c4041f5ff5SPL ID aa61176b-8199-47b9-ae53-66c4041f5ff5SPL set ID 0d5cec96-b02b-4f1d-bc66-51e62ce04e3cRxCUI 2749959, 2749966UNII KR9ZSKO5QE
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
N461755001201followed by a unit qualifier and the quantityPackage 61755-0012-01. 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 .
Indications (excerpt from the label)
PASATRU is indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). PASATRU is an activin signaling inhibitor indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 61755-012
- What is NDC 61755-012?
- 61755-012 is the product NDC for Pasatru (garetosmab-grts), Garetosmab 300 mg/5mL injection, solution, concentrate, listed with the FDA by Regeneron Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pasatru (Garetosmab-grts).
- What is the active ingredient?
- Garetosmab.
- Who is the labeler?
- Regeneron Pharmaceuticals, Inc., NDC labeler code 61755. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pasatru?
- 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.