Prescription drug · ANDA
Doxorubicin Hydrochloride NDC 47335-049
Doxorubicin hydrochloride 2 mg/mL · Injectable, Liposomal · Intravenous · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-049-40 | 4733500494047335004940 | 1 VIAL, SINGLE-DOSE in 1 PACKAGE (47335-049-40) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 5, 2013 |
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)
- Doxorubicin Hydrochloride
- Generic name (nonproprietary)
- doxorubicin hydrochloride
- Active ingredients
- Doxorubicin hydrochloride — 2 mg/mL
- Dosage form
- Injectable, Liposomal
- Route
- Intravenous
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203263
- Marketing start
- Listing expires
- Other FDA classes
- Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 47335-049_efff8fef-d079-4581-8027-646e57a23c62SPL ID efff8fef-d079-4581-8027-646e57a23c62SPL set ID fbc48fa5-0bfb-4957-b13c-a56bb7a13b56RxCUI 1790115, 1790127UNII 82F2G7BL4EUPC 0347335050400
- 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
N447335004940followed by a unit qualifier and the quantityPackage 47335-0049-40. 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 hydrochloride is an anthracycline topoisomerase inhibitor indicated for: Ovarian cancer: After failure of platinum-based chemotherapy (1.1). AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy (1.2). Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy (1.3). 1.1 Ovarian Cancer Doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. 1.2 AIDS-Related Kaposi's Sarcoma Doxorubicin hydrochloride liposome inje…
Excerpt only. Read the full label for complete information.
About NDC 47335-049
- What is NDC 47335-049?
- 47335-049 is the product NDC for Doxorubicin Hydrochloride, Doxorubicin hydrochloride 2 mg/mL injectable, liposomal, listed with the FDA by Sun Pharmaceutical Industries, 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 203263
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 | Injectable, LiposomalIntravenous | Sun Pharmaceutical Industries, Inc. | 47335-050 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injectable, LiposomalIntravenous | BluePoint Laboratories | 68001-492 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injectable, LiposomalIntravenous | BluePoint Laboratories | 68001-493 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injectable, LiposomalIntravenous | NorthStar RxLLC | 72603-103 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injectable, LiposomalIntravenous | NorthStar RxLLC | 72603-200 |