sodium fluoride f 18

Generic: sodium fluoride f 18

Labeler: petnet solutions, 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 petnet solutions, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

sodium fluoride f-18 200 mCi/mL

Manufacturer
PETNET Solutions, Inc.

Identifiers & Regulatory

Product NDC 40028-512
Product ID 40028-512_473094ba-f056-3ceb-e063-6294a90a567e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203890
Listing Expiration 2026-12-31
Marketing Start 2011-01-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 40028512
Hyphenated Format 40028-512

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 ANDA203890 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mCi/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CAN (40028-512-30) / 30 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

40028-512-30 1 VIAL, MULTI-DOSE in 1 CAN (40028-512-30) / 30 mL in 1 VIAL, MULTI-DOSE

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": "473094ba-f056-3ceb-e063-6294a90a567e", "openfda": {"unii": ["9L75099X6R"], "spl_set_id": ["9a186741-f26c-4261-b1cb-25495497c7a2"], "manufacturer_name": ["PETNET Solutions, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CAN (40028-512-30)  / 30 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "40028-512-30", "marketing_start_date": "20110126"}], "brand_name": "Sodium Fluoride F 18", "product_id": "40028-512_473094ba-f056-3ceb-e063-6294a90a567e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "40028-512", "generic_name": "Sodium Fluoride F 18", "labeler_name": "PETNET Solutions, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Fluoride F 18", "active_ingredients": [{"name": "SODIUM FLUORIDE F-18", "strength": "200 mCi/mL"}], "application_number": "ANDA203890", "marketing_category": "ANDA", "marketing_start_date": "20110126", "listing_expiration_date": "20261231"}