Prescription drug · NDA
Bortezomib NDC 63759-3032
Bortezomib 3.5 mg/1.4mL · Injection · Intravenous, Subcutaneous · Shilpa Medicare Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63759-3032-1 | 6375930320163759303201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63759-3032-1) / 1.4 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 25, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Bortezomib
- Generic name (nonproprietary)
- bortezomib
- Active ingredients
- Bortezomib — 3.5 mg/1.4mL
- Dosage form
- Injection
- Route
- Intravenous, Subcutaneous
- Labeler
- Shilpa Medicare LimitedNDC labeler code 63759
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212782
- Marketing start
- Listing expires
- Other FDA classes
- Proteasome Inhibitors (Mechanism)
- Identifiers
- Product ID 63759-3032_71ebcbb5-31e2-4394-8a38-d833fd3c733aSPL ID 71ebcbb5-31e2-4394-8a38-d833fd3c733aSPL set ID 61539d49-dc21-4576-8813-4bc8abf3868cRxCUI 2608948UNII 69G8BD63PPUPC 0363759303212
- Pharmacologic class
- Proteasome 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
N463759303201followed by a unit qualifier and the quantityPackage 63759-3032-01. 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 .
Indications (excerpt from the label)
Bortezomib Injection is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma ( 1.1 ) treatment of adult patients with mantle cell lymphoma ( 1.2 ) 1.1 Multiple Myeloma Bortezomib Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib Injection is indicated for the treatment of adult patients with mantle cell lymphoma.
Excerpt only. Read the full label for complete information.
About NDC 63759-3032
- What is NDC 63759-3032?
- 63759-3032 is the product NDC for Bortezomib, Bortezomib 3.5 mg/1.4mL injection, listed with the FDA by Shilpa Medicare Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bortezomib.
- What is the active ingredient?
- Bortezomib.
- Who is the labeler?
- Shilpa Medicare Limited, NDC labeler code 63759. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bortezomib?
- 29 other product NDCs are listed under this name. See all Bortezomib NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bortezomib products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bortezomib | Bortezomib 3.5 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Avenacy, LLC | 83634-208 | 83634-0208-10 |
| Bortezomib | Bortezomib 1 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Gland Pharma Limited | 68083-650 | 68083-0650-01 |
| Bortezomib | Bortezomib 2.5 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Gland Pharma Limited | 68083-651 | 68083-0651-01 |
| Bortezomib | Bortezomib 3.5 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Ningbo Shuangcheng Pharmaceutical Co., Ltd. | 75007-501 | 75007-0501-3175007-0501-32 |
| Bortezomib | Bortezomib 3.5 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Sagent Pharmaceuticals | 25021-262 | 25021-0262-10 |
| Bortezomib | Bortezomib 3.5 mg/3.5mL | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Somerset Therapeutics LLC | 70069-836 | 70069-0836-01 |
| Bortezomib | Bortezomib 3.5 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | NorthStar RxLLC | 72603-270 | 72603-0270-01 |
| Bortezomib | Bortezomib 3.5 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Camber Pharmaceuticals, Inc. | 31722-303 | 31722-0303-31 |
| Bortezomib | Bortezomib 3.5 mg/3.5mL | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Sintetica US LLC | 83090-008 | 83090-0008-01 |
| Bortezomib | Bortezomib 1 mg/1 | InjectionIntravenous | MAIA Pharmaceuticals, Inc. | 70511-161 | 70511-0161-05 |
Other NDCs under NDA 212782
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 |
|---|---|---|---|---|
| Boruzubortezomib | Bortezomib 3.5 mg/1.4mL | InjectionIntravenous, Subcutaneous | Amneal Pharmaceuticals LLC | 70121-2484 |