Signifor
- Product NDC
- 55292-133
- 11-digit product format
- 552920133
- Labeler code
- 55292
- Product ID
- 55292-133_19a67a21-b599-41d1-9a7c-a5d31972d885
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pasireotide
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Recordati Rare Diseases, Inc.
- Application
- NDA200677
- Marketing category
- NDA
- Marketing start
- 2012-12-14
- Substance
- PASIREOTIDE
- Active strength
- .9 mg/mL
- Pharmacologic classes
- Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Signifor
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PASIREOTIDE | .9 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 98H1T17066 |
| Rxcui | 1364109, 1364114, 1364116, 1364118, 1364120, 1364122 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 093f5f72-95bf-45e6-8f9d-fb29c1364d06 | Product name | 2 | 20180817 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55292-133-01 | Signifor | 1 mL in 1 AMPULE | INJECTION | 1 | 20 | |
| 55292-133-06 | Signifor | 6 in 1 PACKAGE | INJECTION | 6 | 20 | |
| 55292-133-60 | Signifor | 60 in 1 BOX | INJECTION | 60 | 20 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55292-133-60 | ML - Milliliter | 55292-133 | 34dec511-941b-4bd4-a9e4-744ab24dd92d | 1 | 2020-09-14 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1364109 | pasireotide 0.3 MG in 1 ML Injection | PSN | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364116 | pasireotide 0.6 MG in 1 ML Injection | PSN | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364120 | pasireotide 0.9 MG in 1 ML Injection | PSN | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364114 | Signifor 0.3 MG in 1 ML Injection | PSN | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364118 | Signifor 0.6 MG in 1 ML Injection | PSN | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364122 | Signifor 0.9 MG in 1 ML Injection | PSN | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364114 | 1 ML pasireotide 0.3 MG/ML Injection [Signifor] | SBD | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364118 | 1 ML pasireotide 0.6 MG/ML Injection [Signifor] | SBD | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364122 | 1 ML pasireotide 0.9 MG/ML Injection [Signifor] | SBD | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364109 | 1 ML pasireotide 0.3 MG/ML Injection | SCD | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364116 | 1 ML pasireotide 0.6 MG/ML Injection | SCD | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364120 | 1 ML pasireotide 0.9 MG/ML Injection | SCD | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364109 | pasireotide (as pasireotide diaspartate) 0.3 MG per 1 ML Injection | SY | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364116 | pasireotide (as pasireotide diaspartate) 0.6 MG per 1 ML Injection | SY | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364120 | pasireotide (as pasireotide diaspartate) 0.9 MG per 1 ML Injection | SY | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364109 | pasireotide 0.3 MG per 1 ML Injection | SY | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364116 | pasireotide 0.6 MG per 1 ML Injection | SY | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364120 | pasireotide 0.9 MG per 1 ML Injection | SY | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364114 | Signifor (as pasireotide diaspartate) 0.3 MG per 1 ML Injection | SY | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364118 | Signifor (as pasireotide diaspartate) 0.6 MG per 1 ML Injection | SY | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364122 | Signifor (as pasireotide diaspartate) 0.9 MG per 1 ML Injection | SY | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364114 | Signifor 0.3 MG per 1 ML Injection | SY | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364118 | Signifor 0.6 MG per 1 ML Injection | SY | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
| 1364122 | Signifor 0.9 MG per 1 ML Injection | SY | a09a25fc-a5a3-0c82-e053-2995a90a5d74 | 20 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55292-133-01 | 55292013301 | 1 mL in 1 AMPULE | 1 ml | Historical | ||||
| 55292-133-06 | 55292013306 | 6 in 1 PACKAGE | Historical | |||||
| 55292-133-60 | 55292013360 | 60 PACKAGE in 1 BOX (55292-133-60) / 6 AMPULE in 1 PACKAGE (55292-133-06) / 1 mL in 1 AMPULE (55292-133-01) | 60 package | 2012-12-14 | 0000-00-00 | No | No | Current |