Home NDC 13267-346 Fluorodopa
Product NDC 13267-346
11-digit product format 132670346
Labeler code 13267
Product ID 13267-346_f8d69c66-d9aa-4bb8-bb56-5bebeef87af5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluorodopa F18
Dosage form INJECTION
Route INTRAVENOUS
Labeler THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
Application NDA200655
Marketing category NDA
Marketing start 2019-10-10
Substance FLUORODOPA F-18
Active strength 40 mCi/mL
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 N200655-001 FLUORODOPA F18 FLUORODOPA F-18 1-40mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10
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.
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 N200655-001 FLUORODOPA F18 1-40mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N200655-001 FLUORODOPA F18 1-40mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200655-001 FLUORODOPA F18 1-40mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N200655-001 FLUORODOPA F18 1-40mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200655-001 FLUORODOPA F18 1-40mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD 2019-10-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD 2019-10-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD 2019-10-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD 2019-10-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD 2019-10-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N200655-001 FLUORODOPA F18 0.42-8.33mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N200655-001 FLUORODOPA F18 1-40mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-10-10 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluorodopa
Brand name suffix F18
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUORODOPA F-18 40 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2C598205QX 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 13267-346-57 FluorodopaF18 30 mL in 1 VIAL, GLASS INJECTION 30 20210115
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13267-346 FLUORODOPA F18 INJECTION [THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH] 20210115 Current NDC, Legacy NDC, 1 package rows 20210116_37f8c405-ccb6-4fcd-8513-108956bb1674.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 Units Marketing start Marketing end Sample Exclude flag Status 13267-346-57 13267034657 30 mL in 1 VIAL, GLASS (13267-346-57) 30 ml 2019-10-10 0000-00-00 No No Current