Home NDC 11994-011 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021064-001 DEFINITY PERFLUTREN 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 N021064-002 DEFINITY RT PERFLUTREN 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
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 · 78 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 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021064-001 DEFINITY 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021064-002 DEFINITY RT 13.04MG/2ML (6.52MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021064-001 DEFINITY 6.52MG/ML INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021064-002 DEFINITY RT 6.52MG/ML INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021064-001 DEFINITY 6.52MG/ML INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021064-002 DEFINITY RT 6.52MG/ML INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021064-001 DEFINITY 6.52MG/ML INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021064-002 DEFINITY RT 6.52MG/ML INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021064-001 DEFINITY 6.52MG/ML INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021064-001 DEFINITY 6.52MG/ML INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021064-002 DEFINITY RT 6.52MG/ML INJECTABLE / INTRAVENOUS RLD, RS 2020-11-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021064-001 DEFINITY 6.52MG/ML INJECTABLE / INTRAVENOUS RLD, RS 2001-07-31 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 15 · 572 observed states.
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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 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
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 · 2 matching rows.
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