Prescription drug · NDA
Signifor LAR (Pasireotide) NDC 55292-139
Kit · Recordati Rare Diseases, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55292-139-01 | 55292013901 | 1 KIT in 1 KIT (55292-139-01) * 6 mL in 1 VIAL, SINGLE-USE (55292-134-01) * 2 mL in 1 SYRINGEMarketed from Jun 29, 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)
- Signifor LAR
- Generic name (nonproprietary)
- pasireotide
- Dosage form
- Kit
- Labeler
- Recordati Rare Diseases, Inc.NDC labeler code 55292
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203255
- Marketing start
- Listing expires
- Identifiers
- Product ID 55292-139_fb5687ef-6bbc-4ac4-899e-46c941f214c5SPL ID fb5687ef-6bbc-4ac4-899e-46c941f214c5SPL set ID a0aad470-3f38-af97-e053-2995a90a383aRxCUI 1597596, 1597599, 1597601, 1597603, 1597820, 1597822, 2049730, 2049732, 2049734, 2049736
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
N455292013901followed by a unit qualifier and the quantityPackage 55292-0139-01. 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)
SIGNIFOR LAR is a somatostatin analog indicated for the treatment of: Patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. ( 1.1 ) Patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. ( 1.2 ) 1.1 Acromegaly SIGNIFOR LAR is indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. 1.2 Cushing's Disease SIGNIFOR LAR is indicated for the treatment of 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 55292-139
- What is NDC 55292-139?
- 55292-139 is the product NDC for Signifor LAR (pasireotide) kit, 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 LAR (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 LAR?
- 4 other product NDCs are listed under this name. See all Signifor LAR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Signifor LAR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Signifor LARpasireotide | — | Kit | Recordati Rare Diseases, Inc. | 55292-140 | 55292-0140-01 |
| Signifor LARpasireotide | — | Kit | Recordati Rare Diseases, Inc. | 55292-141 | 55292-0141-01 |
| Signifor LARpasireotide | — | Kit | Recordati Rare Diseases, Inc. | 55292-142 | 55292-0142-01 |
| Signifor LARpasireotide | — | Kit | Recordati Rare Diseases, Inc. | 55292-143 | 55292-0143-01 |
Other NDCs under NDA 203255
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 |
|---|---|---|---|---|
| Signifor LARpasireotide | — | Kit | Recordati Rare Diseases, Inc. | 55292-140 |
| Signifor LARpasireotide | — | Kit | Recordati Rare Diseases, Inc. | 55292-141 |
| Signifor LARpasireotide | — | Kit | Recordati Rare Diseases, Inc. | 55292-142 |
| Signifor LARpasireotide | — | Kit | Recordati Rare Diseases, Inc. | 55292-143 |