Prescription drug · BLA
Zomacton (Somatropin) NDC 55566-1801
Kit · Ferring Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55566-1801-1 | 5556618010155566180101 | 1 KIT in 1 CARTON (55566-1801-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 5 mL in 1 VIAL (55566-2000-0)Marketed from May 7, 2015 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Zomacton
- Generic name (nonproprietary)
- somatropin
- Dosage form
- Kit
- Labeler
- Ferring Pharmaceuticals Inc.NDC labeler code 55566
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 019774
- Marketing start
- Listing expires
- Identifiers
- Product ID 55566-1801_a22b3e28-f61a-4164-891a-395fca12b7afSPL ID a22b3e28-f61a-4164-891a-395fca12b7afSPL set ID 85ba081b-bee0-4a9a-aa0f-ae5b5e9a0886RxCUI 241975, 284989, 1648160, 1648162
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.
- NDC on a medical claim
N455566180101followed by a unit qualifier and the quantityPackage 55566-1801-01. 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)
ZOMACTON is a recombinant human growth hormone indicated for: Pediatric: Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Turner syndrome, idiopathic short stature (ISS), short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years. ( 1.1 ) Adult: Replacement of endogenous GH in adults with GH deficiency ( 1.2 ) 1.1 Pediatric Patients ZOMACTON is indicated for the treatment of pediatric patients with: growth failure due to inadequate secretion of endogenous growth ho…
Excerpt only. Read the full label for complete information.
About NDC 55566-1801
- What is NDC 55566-1801?
- 55566-1801 is the product NDC for Zomacton (somatropin) kit, listed with the FDA by Ferring Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zomacton (Somatropin).
- Who is the labeler?
- Ferring Pharmaceuticals Inc., NDC labeler code 55566. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zomacton?
- 1 other product NDC are listed under this name. See all Zomacton NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zomacton products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zomactonsomatropin | — | KitSubcutaneous | Ferring Pharmaceuticals Inc. | 55566-1901 | 55566-1901-01 |
Other NDCs under BLA 019774
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 |
|---|---|---|---|---|
| Zomactonsomatropin | — | KitSubcutaneous | Ferring Pharmaceuticals Inc. | 55566-1901 |