Home NDC 49609-102-01 Sodium Fluoride F 18
Product NDC 49609-102
Requested package NDC 49609-102-01
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 1 .
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.
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 2026-08-01 22:54:32 2026-06 A203592-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-08-18 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A203592-001 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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