sodium fluoride f 18

Generic: sodium fluoride f-18

Labeler: bamf health inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium fluoride f 18
Generic Name sodium fluoride f-18
Labeler bamf health inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

sodium fluoride f-18 200 mCi/mL

Manufacturer
BAMF Health Inc.

Identifiers & Regulatory

Product NDC 81759-002
Product ID 81759-002_0da6e293-9150-3146-e063-6394a90a0399
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204328
Listing Expiration 2026-12-31
Marketing Start 2022-12-06

Pharmacologic Class

Classes
radioactive diagnostic agent [epc] radiopharmaceutical activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81759002
Hyphenated Format 81759-002

Supplemental Identifiers

UNII
9L75099X6R

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sodium fluoride f 18 (source: ndc)
Generic Name sodium fluoride f-18 (source: ndc)
Application Number ANDA204328 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mCi/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CONTAINER (81759-002-30) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

81759-002-30 1 VIAL, GLASS in 1 CONTAINER (81759-002-30) / 10 mL in 1 VIAL, GLASS

Ingredients (1)

sodium fluoride f-18 (200 mCi/mL)

Linked Drug Pages (1)

Sodium Fluoride F 18 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0da6e293-9150-3146-e063-6394a90a0399", "openfda": {"unii": ["9L75099X6R"], "spl_set_id": ["ef58c3cd-a922-c5fc-e053-2a95a90a9d74"], "manufacturer_name": ["BAMF Health Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CONTAINER (81759-002-30)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "81759-002-30", "marketing_start_date": "20221206"}], "brand_name": "Sodium Fluoride F 18", "product_id": "81759-002_0da6e293-9150-3146-e063-6394a90a0399", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "81759-002", "generic_name": "SODIUM FLUORIDE F-18", "labeler_name": "BAMF Health Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Fluoride", "brand_name_suffix": "F 18", "active_ingredients": [{"name": "SODIUM FLUORIDE F-18", "strength": "200 mCi/mL"}], "application_number": "ANDA204328", "marketing_category": "ANDA", "marketing_start_date": "20221206", "listing_expiration_date": "20261231"}