Prescription drug · BLA
Ruconest (C1 esterase inhibitor recombinant) NDC 71274-350
Conestat alfa 2100 U/1 · Injection, Powder, For solution · Intravenous · Pharming Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71274-350-02 | 71274035002 | 1 VIAL, SINGLE-USE in 1 CARTON (71274-350-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (71274-350-01)Marketed from Apr 1, 2018 |
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)
- Ruconest
- Generic name (nonproprietary)
- c1 esterase inhibitor recombinant
- Active ingredients
- Conestat alfa — 2100 U/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Pharming Healthcare Inc.NDC labeler code 71274
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125495
- Marketing start
- Listing expires
- Identifiers
- Product ID 71274-350_a742815a-7705-9153-e053-2995a90a562dSPL ID a742815a-7705-9153-e053-2995a90a562dSPL set ID 66d3fecb-32a4-7781-e053-2a91aa0a83caRxCUI 1599836, 1599841UNII 5QS67N4551
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
N471274035002followed by a unit qualifier and the quantityPackage 71274-0350-02. 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)
RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks. RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). ( 1 ) Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks.
Excerpt only. Read the full label for complete information.
About NDC 71274-350
- What is NDC 71274-350?
- 71274-350 is the product NDC for Ruconest (c1 esterase inhibitor recombinant), Conestat alfa 2100 U/1 injection, powder, for solution, listed with the FDA by Pharming Healthcare Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ruconest (C1 esterase inhibitor recombinant).
- What is the active ingredient?
- Conestat alfa.
- Who is the labeler?
- Pharming Healthcare Inc., NDC labeler code 71274. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ruconest?
- 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.