Prescription drug · ANDA
Deferoxamine mesylate NDC 68083-173
Deferoxamine mesylate 2 g/1 · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous, Subcutaneous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-173-01 | 68083017301 | 4 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68083-173-01)Marketed from Oct 9, 2017 |
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 mesylate
- Generic name (nonproprietary)
- deferoxamine mesylate
- Active ingredients
- Deferoxamine mesylate — 2 g/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207384
- Marketing start
- Listing expires
- Other FDA classes
- Iron Chelating Activity (Mechanism)
- Identifiers
- Product ID 68083-173_d14a31c5-4e8d-4e3e-b38f-d73ffddfb629SPL ID d14a31c5-4e8d-4e3e-b38f-d73ffddfb629SPL set ID 598fba68-f46e-4b6e-894c-63c2940b2063RxCUI 1731345, 1731350UNII V9TKO7EO6K
- 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
N468083017301followed by a unit qualifier and the quantityPackage 68083-0173-01. 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 68083-173
- What is NDC 68083-173?
- 68083-173 is the product NDC for Deferoxamine mesylate, Deferoxamine mesylate 2 g/1 injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Deferoxamine mesylate.
- What is the active ingredient?
- Deferoxamine mesylate.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. 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 mesylate?
- 4 other product NDCs are listed under this name. See all Deferoxamine mesylate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Deferoxamine mesylate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Deferoxamine mesylate | Deferoxamine mesylate 500 mg/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous, Subcutaneous | Apotex Corp. | 60505-6236 | 60505-6236-06 |
| Deferoxamine mesylate | Deferoxamine mesylate 2 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6237 | 60505-6237-06 |
| Deferoxamine mesylate | Deferoxamine mesylate 500 mg/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous, Subcutaneous | Gland Pharma Limited | 68083-172 | 68083-0172-01 |
| Deferoxamine Mesylate | Deferoxamine mesylate 2 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous, Subcutaneous | Hospira, Inc. | 0409-2337 | 00409-2337-25 |
Other NDCs under ANDA 207384
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 |
|---|---|---|---|---|
| Deferoxamine mesylate | Deferoxamine mesylate 500 mg/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous, Subcutaneous | Apotex Corp. | 60505-6236 |
| Deferoxamine mesylate | Deferoxamine mesylate 2 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6237 |
| Deferoxamine mesylate | Deferoxamine mesylate 500 mg/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous, Subcutaneous | Gland Pharma Limited | 68083-172 |