Optison
- Product NDC
- 0407-2707
- 11-digit product format
- 004072707
- Labeler code
- 0407
- Product ID
- 0407-2707_37a56077-bf10-4afa-b405-7f80967f41e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Human Albumin Microspheres and Perflutren
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- GE Healthcare Inc.
- Application
- NDA020899
- Marketing category
- NDA
- Marketing start
- 2002-01-02
- Substance
- HUMAN ALBUMIN MICROSPHERES; PERFLUTREN
- Active strength
- 10; .22 mg/mL; mg/mL
- Pharmacologic classes
- Contrast Agent for Ultrasound Imaging [EPC], Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA], 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
- Optison
- Brand name suffix
- Perflutren Protein-Type A Microspheres
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN ALBUMIN MICROSPHERES | 10 mg/mL |
| PERFLUTREN | .22 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | T8C6W1N6NW, CK0N3WH0SR |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0407-2707-03 | OptisonPerflutren Protein-Type A Microspheres | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 24 |
| 0407-2707-03 | OptisonPerflutren Protein-Type A Microspheres | 3 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 3 | | 24 |
| 0407-2707-18 | OptisonPerflutren Protein-Type A Microspheres | 18 in 1 CARTON | INJECTION, SOLUTION | 18 | | 24 |
| 0407-2707-18 | OptisonPerflutren Protein-Type A Microspheres | 3 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 3 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Human Albumin Microspheres | ACTIVE INGREDIENT | T8C6W1N6NW | OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES (HUMAN ALBUMIN MICROSPHERES AND PERFLUTREN) INJECTION, SOLUTION [GE HEALTHCARE INC.] | 10 | |
| Perflutren | ACTIVE INGREDIENT | CK0N3WH0SR | OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES (HUMAN ALBUMIN MICROSPHERES AND PERFLUTREN) INJECTION, SOLUTION [GE HEALTHCARE INC.] | 10 | |
| Human Albumin Microspheres | ACTIVE MOIETY | T8C6W1N6NW | OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES (HUMAN ALBUMIN MICROSPHERES AND PERFLUTREN) INJECTION, SOLUTION [GE HEALTHCARE INC.] | 10 | |
| Perflutren | ACTIVE MOIETY | CK0N3WH0SR | OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES (HUMAN ALBUMIN MICROSPHERES AND PERFLUTREN) INJECTION, SOLUTION [GE HEALTHCARE INC.] | 10 | |
| Acetyltryptophan, Dl- | INACTIVE INGREDIENT | 4460NBV53F | OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES (HUMAN ALBUMIN MICROSPHERES AND PERFLUTREN) INJECTION, SOLUTION [GE HEALTHCARE INC.] | 10 | |
| Octanoic Acid | INACTIVE INGREDIENT | OBL58JN025 | OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES (HUMAN ALBUMIN MICROSPHERES AND PERFLUTREN) INJECTION, SOLUTION [GE HEALTHCARE INC.] | 10 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES (HUMAN ALBUMIN MICROSPHERES AND PERFLUTREN) INJECTION, SOLUTION [GE HEALTHCARE INC.] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0407-2707 | OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES (HUMAN ALBUMIN MICROSPHERES AND PERFLUTREN) INJECTION, SOLUTION [GE HEALTHCARE INC.] | 22 | Current NDC, Legacy NDC, 4 package rows | 20250522_46bcf276-d423-408a-a410-f11383406a94.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0407-2707-03 | 00407270703 | 5 VIAL, SINGLE-USE in 1 CARTON (0407-2707-03) / 3 mL in 1 VIAL, SINGLE-USE | 2002-01-02 | 0000-00-00 | No | No | Current |
| 0407-2707-18 | 00407270718 | 18 VIAL, SINGLE-USE in 1 CARTON (0407-2707-18) / 3 mL in 1 VIAL, SINGLE-USE | 2002-01-02 | 0000-00-00 | No | No | Current |