Prescription drug · ANDA
Doxorubicin Hydrochloride NDC 0143-9089
Doxorubicin hydrochloride 2 mg/mL · Injection, Solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9089-01 | 0014390890100143908901 | 1 VIAL in 1 BOX (0143-9089-01) / 10 mL in 1 VIALMarketed from Oct 1, 2019 |
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)
- Doxorubicin Hydrochloride
- Generic name (nonproprietary)
- doxorubicin hydrochloride
- Active ingredients
- Doxorubicin hydrochloride — 2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062975
- Marketing start
- Listing expires
- Other FDA classes
- Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 0143-9089_7c916380-3ae0-4a64-945d-7b0da46b9715SPL ID 7c916380-3ae0-4a64-945d-7b0da46b9715SPL set ID 971de64b-ff09-4370-afd9-6eb1093ad27dRxCUI 1191138, 1790097, 1790099, 1790100UNII 82F2G7BL4E
- 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
N400143908901followed by a unit qualifier and the quantityPackage 00143-9089-01. 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)
Doxorubicin is an anthracycline topoisomerase II inhibitor indicated: as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ). for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma ( 1.2 ). 1.1 Adjuvant Breast Cancer D…
Excerpt only. Read the full label for complete information.
About NDC 0143-9089
- What is NDC 0143-9089?
- 0143-9089 is the product NDC for Doxorubicin Hydrochloride, Doxorubicin hydrochloride 2 mg/mL injection, solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Doxorubicin Hydrochloride.
- What is the active ingredient?
- Doxorubicin hydrochloride.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Doxorubicin Hydrochloride?
- 54 other product NDCs are listed under this name. See all Doxorubicin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Doxorubicin Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| doxorubicin hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, Suspension, LiposomalIntravenous | BluePoint Laboratories | 68001-706 | 68001-0706-36 |
| doxorubicin hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, Suspension, LiposomalIntravenous | BluePoint Laboratories | 68001-707 | 68001-0707-26 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injectable, LiposomalIntravenous | BluePoint Laboratories | 68001-703 | 68001-0703-36 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injectable, LiposomalIntravenous | BluePoint Laboratories | 68001-704 | 68001-0704-26 |
| doxorubicin hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, Suspension, LiposomalIntravenous | Alembic Pharmaceuticals Limited | 46708-525 | 46708-0525-25 |
| doxorubicin hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, Suspension, LiposomalIntravenous | Alembic Pharmaceuticals Limited | 46708-810 | 46708-0810-10 |
| doxorubicin hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, Suspension, LiposomalIntravenous | Alembic Pharmaceuticals Inc. | 62332-525 | 62332-0525-25 |
| doxorubicin hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, Suspension, LiposomalIntravenous | Alembic Pharmaceuticals Inc. | 62332-810 | 62332-0810-10 |
| doxorubicin hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, Suspension, LiposomalIntravenous | Dr. Reddy's Laboratories Inc. | 75907-363 | 75907-0363-01 |
| doxorubicin hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, Suspension, LiposomalIntravenous | Dr. Reddy's Laboratories Inc. | 75907-364 | 75907-0364-01 |
Other NDCs under ANDA 062975
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 |
|---|---|---|---|---|
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9084 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9085 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9086 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9088 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9090 |