Home NDC 0407-2707 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020899-001 OPTISON ALBUMIN HUMAN 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N020899-001 NPP 2028-05-09
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020899-001 OPTISON 10MG/ML INJECTABLE / INJECTION RLD, RS 1997-12-31 e64feba35796…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N020899-001 6723303 2021-04-20 Drug product 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N020899-001 6723303 2021-04-20 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020899-001 6723303 2021-04-20 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020899-001 6723303 2021-04-20 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020899-001 6723303 2021-04-20 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020899-001 6723303 2021-04-20 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020899-001 6723303 2021-04-20 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020899-001 6723303 2021-04-20 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020899-001 6723303 2021-04-20 Drug product ea99ee380514…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 N020899-001 NPP 2028-05-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020899-001 NPP 2028-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020899-001 NPP 2028-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020899-001 NPP 2028-05-09 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020899-001 NPP 2028-05-09 a50c72e98297…
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 UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T8C6W1N6NW Internal UNII lookup CK0N3WH0SR Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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