Prescription drug · ANDA
Idarubicin Hydrochloride NDC 0143-9308
Idarubicin hydrochloride 1 mg/mL · Injection, Solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9308-01 | 00143930801 | 1 VIAL, GLASS in 1 BOX (0143-9308-01) / 20 mL in 1 VIAL, GLASSMarketed from Jan 12, 2018 |
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)
- Idarubicin Hydrochloride
- Generic name (nonproprietary)
- idarubicin hydrochloride
- Active ingredients
- Idarubicin hydrochloride — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065275
- Marketing start
- Listing expires
- Other FDA classes
- Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 0143-9308_c78bf879-433f-4805-ad7b-5fa3002a75dbSPL ID c78bf879-433f-4805-ad7b-5fa3002a75dbSPL set ID 7c20b574-285b-49eb-a98e-6752e4bb481dRxCUI 1791493, 1791498, 1791500UNII 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
N400143930801followed by a unit qualifier and the quantityPackage 00143-9308-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Idarubicin Hydrochloride injection, USP in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065275
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 |
|---|---|---|---|---|
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9217 |
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9218 |
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9219 |
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9306 |
| Idarubicin Hydrochloride | Idarubicin hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9307 |