Definity
- Product NDC
- 11994-011
- 11-digit product format
- 119940011
- Labeler code
- 11994
- Product ID
- 11994-011_8b5860ab-6714-4cf0-8679-f7c439fe5131
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- perflutren
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Lantheus Medical Imaging, Inc.
- Application
- NDA021064
- Marketing category
- NDA
- Marketing start
- 2001-07-31
- Substance
- PERFLUTREN
- Active strength
- 6.52 mg/mL
- Pharmacologic classes
- Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Definity
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PERFLUTREN | 6.52 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CK0N3WH0SR |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11994-011-01 | Definity | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 32 |
| 11994-011-01 | Definity | 1.5 mL in 1 VIAL, GLASS | INJECTION, SUSPENSION | 1.5 | | 32 |
| 11994-011-04 | Definity | 1.5 mL in 1 VIAL, GLASS | INJECTION, SUSPENSION | 1.5 | | 32 |
| 11994-011-04 | Definity | 4 in 1 CARTON | INJECTION, SUSPENSION | 4 | | 32 |
| 11994-011-16 | Definity | 1.5 mL in 1 VIAL, GLASS | INJECTION, SUSPENSION | 1.5 | | 32 |
| 11994-011-16 | Definity | 16 in 1 CARTON | INJECTION, SUSPENSION | 16 | | 32 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PERFLUTREN | ACTIVE INGREDIENT | CK0N3WH0SR | DEFINITY (PERFLUTREN) INJECTION, SUSPENSION [LANTHEUS MEDICAL IMAGING, INC.] | 17 | |
| PERFLUTREN | ACTIVE MOIETY | CK0N3WH0SR | DEFINITY (PERFLUTREN) INJECTION, SUSPENSION [LANTHEUS MEDICAL IMAGING, INC.] | 17 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | DEFINITY (PERFLUTREN) INJECTION, SUSPENSION [LANTHEUS MEDICAL IMAGING, INC.] | 17 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DEFINITY (PERFLUTREN) INJECTION, SUSPENSION [LANTHEUS MEDICAL IMAGING, INC.] | 17 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | DEFINITY (PERFLUTREN) INJECTION, SUSPENSION [LANTHEUS MEDICAL IMAGING, INC.] | 17 | |
| SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | INACTIVE INGREDIENT | 70WT22SF4B | DEFINITY (PERFLUTREN) INJECTION, SUSPENSION [LANTHEUS MEDICAL IMAGING, INC.] | 17 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | DEFINITY (PERFLUTREN) INJECTION, SUSPENSION [LANTHEUS MEDICAL IMAGING, INC.] | 17 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11994-011 | DEFINITY (PERFLUTREN) INJECTION, SUSPENSION [LANTHEUS MEDICAL IMAGING, INC.] | 32 | Current NDC, Legacy NDC, 6 package rows | 20240316_8ab9c79c-1b5c-4e86-899c-cc74686f070a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 11994-011-01 | 11994001101 | 1 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASS | 2001-07-31 | 0000-00-00 | No | No | Current |
| 11994-011-04 | 11994001104 | 4 VIAL, GLASS in 1 CARTON (11994-011-04) / 1.5 mL in 1 VIAL, GLASS | 2001-07-31 | 0000-00-00 | No | No | Current |
| 11994-011-16 | 11994001116 | 16 VIAL, GLASS in 1 CARTON (11994-011-16) / 1.5 mL in 1 VIAL, GLASS | 2001-07-31 | 0000-00-00 | No | No | Current |