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NDC 55292-0131-60 Signifor 0.3 mg/mL Details
Signifor 0.3 mg/mL
Signifor is a SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Recordati Rare Diseases, Inc.. The primary component is PASIREOTIDE.
MedlinePlus Drug Summary
Pasireotide injection (Signifor and Signifor LAR) is used to treat Cushing's disease (an abnormal condition that is caused by excess hormones [cortisol]) in adults who cannot be treated with surgery or who did not respond to surgery. Pasireotide injection (Signifor LAR) is also used to decrease the amount of growth hormone (a natural substance) produced by people with acromegaly (condition in which the body produces too much growth hormone, causing enlargement of the hands, feet, and facial features; joint pain; and other symptoms) who cannot be treated with surgery or who did not respond to surgery. Pasireotide injection is in a class of medications called somatostatin agonists. It works by decreasing the amounts of cortisol produced by the body.
Related Packages: 55292-0131-60Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pasireotide Injection
Product Information
| NDC | 55292-0131 |
|---|---|
| Product ID | 55292-131_020b4f40-1cec-b6c3-e063-6294a90a0e57 |
| Associated GPIs | 30170075202020 |
| GCN Sequence Number | 070367 |
| GCN Sequence Number Description | pasireotide diaspartate AMPUL 0.3 MG/ML SUBCUT |
| HIC3 | P1B |
| HIC3 Description | SOMATOSTATIC AGENTS |
| GCN | 33879 |
| HICL Sequence Number | 039866 |
| HICL Sequence Number Description | PASIREOTIDE DIASPARTATE |
| Brand/Generic | Brand |
| Proprietary Name | Signifor |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | pasireotide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 0.3 |
| Active Ingredient Units | mg/mL |
| Substance Name | PASIREOTIDE |
| Labeler Name | Recordati Rare Diseases, Inc. |
| Pharmaceutical Class | Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA200677 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55292-0131-60 (55292013160)
| NDC Package Code | 55292-131-60 |
|---|---|
| Billing NDC | 55292013160 |
| Package | 60 PACKAGE in 1 BOX (55292-131-60) / 6 AMPULE in 1 PACKAGE (55292-131-06) / 1 mL in 1 AMPULE (55292-131-01) |
| Marketing Start Date | 2012-12-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |