Prescription drug · NDA
Signifor (Pasireotide) NDC 55292-132
Pasireotide .6 mg/mL · Injection · Subcutaneous · Recordati Rare Diseases, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55292-132-60 | 55292013260 | 60 PACKAGE in 1 BOX (55292-132-60) / 6 AMPULE in 1 PACKAGE (55292-132-06) / 1 mL in 1 AMPULE (55292-132-01)Marketed from Dec 14, 2012 |
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)
- Signifor
- Generic name (nonproprietary)
- pasireotide
- Active ingredients
- Pasireotide — .6 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Recordati Rare Diseases, Inc.NDC labeler code 55292
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 200677
- Marketing start
- Listing expires
- Other FDA classes
- Somatostatin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 55292-132_19a67a21-b599-41d1-9a7c-a5d31972d885SPL ID 19a67a21-b599-41d1-9a7c-a5d31972d885SPL set ID a09a25fc-a5a3-0c82-e053-2995a90a5d74RxCUI 1364109, 1364114, 1364116, 1364118, 1364120, 1364122UNII 98H1T17066
- Pharmacologic class
- Somatostatin Analog
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
N455292013260followed by a unit qualifier and the quantityPackage 55292-0132-60. 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)
SIGNIFOR is a somatostatin analog indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative ( 1 ) 1.1 Cushing's Disease SIGNIFOR is indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.
Excerpt only. Read the full label for complete information.
About NDC 55292-132
- What is NDC 55292-132?
- 55292-132 is the product NDC for Signifor (pasireotide), Pasireotide .6 mg/mL injection, listed with the FDA by Recordati Rare Diseases, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Signifor (Pasireotide).
- What is the active ingredient?
- Pasireotide.
- Who is the labeler?
- Recordati Rare Diseases, Inc., NDC labeler code 55292. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Signifor?
- 2 other product NDCs are listed under this name. See all Signifor NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Signifor products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Signiforpasireotide | Pasireotide .3 mg/mL | InjectionSubcutaneous | Recordati Rare Diseases, Inc. | 55292-131 | 55292-0131-60 |
| Signiforpasireotide | Pasireotide .9 mg/mL | InjectionSubcutaneous | Recordati Rare Diseases, Inc. | 55292-133 | 55292-0133-60 |
Other NDCs under NDA 200677
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 |
|---|---|---|---|---|
| Signiforpasireotide | Pasireotide .3 mg/mL | InjectionSubcutaneous | Recordati Rare Diseases, Inc. | 55292-131 |
| Signiforpasireotide | Pasireotide .9 mg/mL | InjectionSubcutaneous | Recordati Rare Diseases, Inc. | 55292-133 |