Sodium Fluoride

Product NDC
24275-0285
11-digit product format
242750285
Labeler code
24275
Product ID
24275-0285_80ac682a-6478-46d8-9ab2-46375596478d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride F-18
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
UCSF Radiopharmaceutical Facility
Application
ANDA204437
Marketing category
ANDA
Marketing start
2009-11-01
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct24275-0285DDiscontinued by firm2026-08-17
excluded packagepackage24275-028524275-0285-1DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage24275-0285-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage24275-0285-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage24275-0285-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage24275-0285-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage24275-0285-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage24275-0285-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage24275-0285-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage24275-0285-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage24275-0285-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage24275-0285-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage24275-0285-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage24275-0285-1557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204437-001SODIUM FLUORIDE F-18SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUSAP2014-03-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUSAP2014-03-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUSAP2014-03-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUSAP2014-03-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUSAP2014-03-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUSAP2014-03-133f01610625f2…
2019-09-15 20:21 UTC2019-09A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUSAP2014-03-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUSAP2014-03-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204437-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2014-03-13e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A204437-001AP174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204437-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A204437-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204437-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204437-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204437-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A204437-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204437-001AP1ea99ee380514…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDE F-18ACTIVE INGREDIENT9L75099X6RSODIUM FLUORIDE F 18 (SODIUM FLUORIDE F-18) INJECTION [UCSF RADIOPHARMACEUTICAL FACILITY]3
FLUORIDE ION F-18ACTIVE MOIETY4M4WE5N2GESODIUM FLUORIDE F 18 (SODIUM FLUORIDE F-18) INJECTION [UCSF RADIOPHARMACEUTICAL FACILITY]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24275-0285-12427502850120 mL in 1 VIAL, GLASS (24275-0285-1) 20 ml2009-11-010000-00-00NoNoCurrent