Home NDC 49609-102 Sodium Fluoride F 18
Product NDC 49609-102
11-digit product format 496090102
Labeler code 49609
Product ID 49609-102_31e5cd99-015b-86fa-e063-6394a90ad41b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM FLUORIDE F-18
Dosage form INJECTION
Route INTRAVENOUS
Labeler SOFIE Co.
Application ANDA203592
Marketing category ANDA
Marketing start 2011-12-08
Substance SODIUM FLUORIDE F-18
Active strength 200 mCi/mL
Pharmacologic classes Radioactive Diagnostic Agent [EPC], Radiopharmaceutical 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 A203592-001 SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203592-001 AP
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 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sodium Fluoride F 18
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE F-18 200 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9L75099X6R 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 49609-102-01 Sodium Fluoride F 18 30 mL in 1 VIAL, MULTI-DOSE INJECTION 30 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49609-102 SODIUM FLUORIDE F 18 (SODIUM FLUORIDE F-18) INJECTION [SOFIE CO.] 8 Current NDC, Legacy NDC, 1 package rows 20250406_2bbd8f48-fdf9-45cb-8305-124a03f7a52c.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 Units Marketing start Marketing end Sample Exclude flag Status 49609-102-01 49609010201 30 mL in 1 VIAL, MULTI-DOSE (49609-102-01) 30 ml 2011-12-08 0000-00-00 No No Current