Prescription drug · ANDA
Carmustine NDC 0781-3474
Kit · Sandoz Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-3474-32 | 0078134743200781347432 | 1 KIT in 1 CARTON (0781-3474-32) * 30 mL in 1 VIAL, SINGLE-DOSE (0781-3470-90) * 3 mL in 1 VIAL (0781-3473-93)Marketed from May 26, 2021 |
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)
- Carmustine
- Generic name (nonproprietary)
- carmustine
- Dosage form
- Kit
- Labeler
- Sandoz Inc.NDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211202
- Marketing start
- Listing expires
- Identifiers
- Product ID 0781-3474_2f11b136-33d9-48a8-e063-6294a90a1d37SPL ID 2f11b136-33d9-48a8-e063-6294a90a1d37SPL set ID 82613f4f-05d1-4410-b288-15b6ad0fd069RxCUI 309012UPC 0307813473930
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.
- NDC on a medical claim
N400781347432followed by a unit qualifier and the quantityPackage 00781-3474-32. 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 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, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors ( 1 ) Multiple myeloma-in combination with prednisone ( 1 ) Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs ( 1 ) Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs ( 1 ) Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: Brain tumors gli…
Excerpt only. Read the full label for complete information.
About NDC 0781-3474
- What is NDC 0781-3474?
- 0781-3474 is the product NDC for Carmustine kit, listed with the FDA by Sandoz Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Carmustine.
- Who is the labeler?
- Sandoz Inc., NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Carmustine?
- 12 other product NDCs are listed under this name. See all Carmustine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Carmustine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| carmustine | — | KitIntravenous | Dr. Reddy's Laboratories Inc. | 75907-327 | 75907-0327-11 |
| Carmustine | — | KitIntravenous | KVK-Tech, Inc. | 10702-361 | 10702-0361-99 |
| Carmustine | — | Kit | Alembic Pharmaceuticals Limited | 46708-659 | 46708-0659-02 |
| Carmustine | — | Kit | Alembic Pharmaceuticals Inc. | 62332-659 | 62332-0659-02 |
| Carmustine | — | Kit | Novadoz Pharmaceuticals LLC | 72205-198 | 72205-0198-01 |
| carmustine | — | KitIntravenous | Dr. Reddy's Laboratories Inc. | 43598-628 | 43598-0628-57 |
| Carmustine | — | KitIntravenous | Meitheal Pharmaceuticals Inc. | 71288-126 | 71288-0126-90 |
| Carmustine | — | Kit | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-790 | 23155-0790-41 |
| Carmustine | — | Kit | Navinta LLC | 68475-503 | 68475-0503-01 |
| carmustine | — | Kit | Zydus Pharmaceuticals USA Inc. | 70710-1525 | 70710-1525-09 |