Prescription drug · ANDA
Bortezomib NDC 68083-650
Bortezomib 1 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous, Subcutaneous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-650-01 | 6808306500168083065001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-650-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Jan 6, 2026 |
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)
- Bortezomib
- Generic name (nonproprietary)
- bortezomib
- Active ingredients
- Bortezomib — 1 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219167
- Marketing start
- Listing expires
- Other FDA classes
- Proteasome Inhibitors (Mechanism)
- Identifiers
- Product ID 68083-650_81bfe4b3-5e07-442f-9351-f521de933404SPL ID 81bfe4b3-5e07-442f-9351-f521de933404SPL set ID cd698074-da21-4b53-8f6b-241535a8d598RxCUI 2601542, 2601544UNII 69G8BD63PPUPC 0368083650018
- 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
N468083065001followed by a unit qualifier and the quantityPackage 68083-0650-01. 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 for 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 for Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib for Injection is indicated for the treatment of adult patients with mantle cell lymphoma.
Excerpt only. Read the full label for complete information.
About NDC 68083-650
- What is NDC 68083-650?
- 68083-650 is the product NDC for Bortezomib, Bortezomib 1 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma 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?
- Gland Pharma Limited, NDC labeler code 68083. 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 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/1.4mL | InjectionIntravenous, Subcutaneous | Shilpa Medicare Limited | 63759-3032 | 63759-3032-01 |
| 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 ANDA 219167
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 |
|---|---|---|---|---|
| Bortezomib | Bortezomib 2.5 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Gland Pharma Limited | 68083-651 |