Prescription drug · ANDA
Deferoxamine (Deferoxamine mesylate) NDC 63323-597
Deferoxamine mesylate 95 mg/mL · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous, Subcutaneous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-597-10 | 6332305971063323059710 | 1 VIAL in 1 BOX (63323-597-10) / 5.3 mL in 1 VIALMarketed from Dec 15, 2009 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Deferoxamine
- Generic name (nonproprietary)
- deferoxamine mesylate
- Active ingredients
- Deferoxamine mesylate — 95 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078718
- Marketing start
- Listing expires
- Other FDA classes
- Iron Chelating Activity (Mechanism)
- Identifiers
- Product ID 63323-597_723278d4-d701-4b94-a615-ac07a1305e2dSPL ID 723278d4-d701-4b94-a615-ac07a1305e2dSPL set ID d91e16df-8daa-4cd2-86a2-273eaa2446e0RxCUI 1731345, 1731350UNII V9TKO7EO6KUPC 0363323597108, 0363323599300
- Pharmacologic class
- Iron Chelator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N463323059710followed by a unit qualifier and the quantityPackage 63323-0597-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Deferoxamine Mesylate for Injection is an iron-chelating agent indicated: • As an adjunct to standard measures for the treatment of acute iron intoxication. ( 1.1 ) • For the treatment of transfusional iron overload in patients with chronic anemia. ( 1.2 ) Limitations of Use Deferoxamine Mesylate for Injection is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder). 1.1 Acute Iron Intoxication Deferoxamine Mesylate for Injection is indicated as an adjunct to standard measures for the treatment of acute iron intoxication. 1.2 Chronic Iron Overload Deferoxamine Mesylate for Injection is indicated for the…
Excerpt only. Read the full label for complete information.
About NDC 63323-597
- What is NDC 63323-597?
- 63323-597 is the product NDC for Deferoxamine (deferoxamine mesylate), Deferoxamine mesylate 95 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Deferoxamine (Deferoxamine mesylate).
- What is the active ingredient?
- Deferoxamine mesylate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Deferoxamine?
- 1 other product NDC are listed under this name. See all Deferoxamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Deferoxamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Deferoxaminedeferoxamine mesylate | Deferoxamine mesylate 95 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-599 | 63323-0599-30 |
Other NDCs under ANDA 078718
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Deferoxaminedeferoxamine mesylate | Deferoxamine mesylate 95 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-599 |