Prescription drug · BLA
Increlex (Mecasermin) NDC 71863-216
Mecasermin 40 mg/4mL · Injection · Subcutaneous · Eton Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71863-216-04 | 7186302160471863021604 | 1 VIAL, MULTI-DOSE in 1 CARTON (71863-216-04) / 4 mL in 1 VIAL, MULTI-DOSEMarketed from Apr 16, 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)
- Increlex
- Generic name (nonproprietary)
- mecasermin
- Active ingredients
- Mecasermin — 40 mg/4mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Eton Pharmaceuticals, Inc.NDC labeler code 71863
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 021839
- Marketing start
- Listing expires
- Identifiers
- Product ID 71863-216_52199e09-74a6-6144-e063-6294a90a59e7SPL ID 52199e09-74a6-6144-e063-6294a90a59e7SPL set ID d5b2b0e1-c523-468d-9a0b-4ae4e4a8dbceRxCUI 604806, 615882UNII 7GR9I2683O
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
N471863021604followed by a unit qualifier and the quantityPackage 71863-0216-04. 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)
INCRELEX (mecasermin) injection is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with severe primary IGF- 1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. ( 1 ) Limitations of use: INCRELEX is not a substitute to GH for approved GH indications. Severe Primary IGF-1 Deficiency (Primary IGFD) INCRELEX is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with: severe primary IGF-1 deficiency or growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Severe Primary IGF-1 deficiency (IGFD) is defined by: height standard devia…
Excerpt only. Read the full label for complete information.
About NDC 71863-216
- What is NDC 71863-216?
- 71863-216 is the product NDC for Increlex (mecasermin), Mecasermin 40 mg/4mL injection, listed with the FDA by Eton Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Increlex (Mecasermin).
- What is the active ingredient?
- Mecasermin.
- Who is the labeler?
- Eton Pharmaceuticals, Inc., NDC labeler code 71863. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Increlex?
- 1 other product NDC are listed under this name. See all Increlex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Increlex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Increlexmecasermin | Mecasermin 40 mg/4mL | Injection, SolutionSubcutaneous | Ipsen Biopharmaceuticals, Inc. | 15054-1040 | 15054-1040-05 |
Other NDCs under BLA 021839
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Increlexmecasermin | Mecasermin 40 mg/4mL | Injection, SolutionSubcutaneous | Ipsen Biopharmaceuticals, Inc. | 15054-1040 |