DEFINITY RT
- Product NDC
- 11994-017
- 11-digit product format
- 119940017
- Labeler code
- 11994
- Product ID
- 11994-017_4d13e254-dcc7-460c-9adc-1c812562cef7
- 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
- 2020-10-01
- 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 RT
- 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 |
|---|
| 11994-017-01 | DEFINITY RT | 0.35 mL in 1 VIAL, GLASS | INJECTION, SUSPENSION | 0.35 | | 9 |
| 11994-017-01 | DEFINITY RT | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 9 |
| 11994-017-20 | DEFINITY RT | 0.35 mL in 1 VIAL, GLASS | INJECTION, SUSPENSION | 0.35 | | 9 |
| 11994-017-20 | DEFINITY RT | 20 in 1 CARTON | INJECTION, SUSPENSION | 20 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11994-017 | DEFINITY RT (PERFLUTREN) INJECTION, SUSPENSION [LANTHEUS MEDICAL IMAGING, INC.] | 9 | Current NDC, Legacy NDC, 4 package rows | 20240316_7b9de6ab-a3ac-40c9-8103-139dc7a464a2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 11994-017-01 | 11994001701 | 1 VIAL, GLASS in 1 CARTON (11994-017-01) / .35 mL in 1 VIAL, GLASS | 2020-10-01 | 0000-00-00 | No | No | Current |
| 11994-017-16 | 11994001716 | 16 VIAL, GLASS in 1 CARTON (11994-017-16) > .35 mL in 1 VIAL, GLASS | 2020-10-01 | 0000-00-00 | No | No | Current |
| 11994-017-20 | 11994001720 | 20 VIAL, GLASS in 1 CARTON (11994-017-20) / .35 mL in 1 VIAL, GLASS | 2020-10-01 | 0000-00-00 | No | No | Current |