Prescription drug · ANDA
carmustine NDC 43598-628
Kit · Intravenous · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-628-57 | 43598062857 | 1 KIT in 1 CARTON (43598-628-57) * 3 mL in 1 VIAL (43598-860-11) * 30 mL in 1 VIAL, SINGLE-DOSE (43598-861-11)Marketed from Oct 4, 2021 |
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)
- carmustine
- Generic name (nonproprietary)
- carmustine
- Dosage form
- Kit
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213207
- Marketing start
- Listing expires
- Identifiers
- Product ID 43598-628_b5eebc2d-a329-0d52-d14c-a68bdf446ca5SPL ID b5eebc2d-a329-0d52-d14c-a68bdf446ca5SPL set ID b946c396-34fc-1845-1944-f16028a8447dRxCUI 309012UPC 0343598860114, 0343598861111
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
N443598062857followed by a unit qualifier and the quantityPackage 43598-0628-57. 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)
Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: - Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - Multiple myeloma in combination with prednisone. - Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. - Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs. Carmustine for injection is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: • Brain tumors glioblastoma,…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213207
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 |
|---|---|---|---|---|
| carmustine | — | KitIntravenous | Dr. Reddy's Laboratories Inc. | 75907-327 |