Prescription drug · NDA
Daunorubicin Hydrochloride NDC 0143-9551
Daunorubicin hydrochloride 5 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9551-10 | 00143955110 | 10 VIAL in 1 BOX (0143-9551-10) / 4 mL in 1 VIAL (0143-9551-01)Marketed from Jan 2, 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)
- Daunorubicin Hydrochloride
- Generic name (nonproprietary)
- daunorubicin hydrochloride
- Active ingredients
- Daunorubicin hydrochloride — 5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050731
- Marketing start
- Listing expires
- Other FDA classes
- Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 0143-9551_d77dc365-6db8-4bdc-81fc-7ac80bcc7699SPL ID d77dc365-6db8-4bdc-81fc-7ac80bcc7699SPL set ID 227784a8-ce68-4dd4-8ac5-a65265969677RxCUI 309650, 2002002UNII UD984I04LZ
- 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
N400143955110followed by a unit qualifier and the quantityPackage 00143-9551-10. 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)
INDICATIONS AND USAGE Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 050731
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 |
|---|---|---|---|---|
| Daunorubicin Hydrochloride | Daunorubicin hydrochloride 5 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9550 |