Prescription drug · NDA
Idamycin PFS (Idarubicin hydrochloride) NDC 0013-2586
Idarubicin hydrochloride 1 mg/mL · Solution · Intravenous · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0013-2586-10 | 0001325861000013258610 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2586-10) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 11, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Idamycin PFS
- Generic name (nonproprietary)
- idarubicin hydrochloride
- Active ingredients
- Idarubicin hydrochloride — 1 mg/mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0013
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050734
- Marketing start
- Listing expires
- Other FDA classes
- Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 0013-2586_d504ef4f-8fe8-447e-8fb3-30846fb2e486SPL ID d504ef4f-8fe8-447e-8fb3-30846fb2e486SPL set ID 0a5a6d93-cc1e-4d7f-8da1-446c134503b3RxCUI 1791493, 1791495, 1791498, 1791499, 1791500, 1791501UNII 5VV3MDU5IE
- Pharmacologic class
- Anthracycline Topoisomerase Inhibitor
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
N400013258610followed by a unit qualifier and the quantityPackage 00013-2586-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. IDAMYCIN PFS is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. (1)
Excerpt only. Read the full label for complete information.
About NDC 0013-2586
- What is NDC 0013-2586?
- 0013-2586 is the product NDC for Idamycin PFS (idarubicin hydrochloride), Idarubicin hydrochloride 1 mg/mL solution, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Idamycin PFS (Idarubicin hydrochloride).
- What is the active ingredient?
- Idarubicin hydrochloride.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0013. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Idamycin PFS?
- 2 other product NDCs are listed under this name. See all Idamycin PFS NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Idamycin PFS products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Idamycin PFSidarubicin hydrochloride | Idarubicin hydrochloride 1 mg/mL | SolutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0013-2576 | 00013-2576-05 |
| Idamycin PFSidarubicin hydrochloride | Idarubicin hydrochloride 1 mg/mL | SolutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0013-2596 | 00013-2596-20 |
Other NDCs under NDA 050734
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 |
|---|---|---|---|---|
| Idamycin PFSidarubicin hydrochloride | Idarubicin hydrochloride 1 mg/mL | SolutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0013-2576 |
| Idamycin PFSidarubicin hydrochloride | Idarubicin hydrochloride 1 mg/mL | SolutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0013-2596 |