Prescription drug · ANDA
Bortezomib NDC 72338-200
Bortezomib 3.5 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous, Subcutaneous · Waverley Pharma Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72338-200-01 | 7233802000172338020001 | 1 VIAL in 1 CARTON (72338-200-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Jun 19, 2018 |
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 — 3.5 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Waverley Pharma IncNDC labeler code 72338
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211898
- Marketing start
- Listing expires
- Other FDA classes
- Proteasome Inhibitors (Mechanism)
- Identifiers
- Product ID 72338-200_c7ce3b3b-d310-47b5-9173-e84abab715f6SPL ID c7ce3b3b-d310-47b5-9173-e84abab715f6SPL set ID a73d7ea7-d068-4d25-b368-fc3db1898be2RxCUI 402243UNII 69G8BD63PPUPC 0372338200019
- 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
N472338020001followed by a unit qualifier and the quantityPackage 72338-0200-01. 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 patients with multiple myeloma ( 1.1 ) treatment of patients with mantle cell lymphoma ( 1.2 ) 1.1 Multiple Myeloma Bortezomib for Injection (bortezomib) 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 72338-200
- What is NDC 72338-200?
- 72338-200 is the product NDC for Bortezomib, Bortezomib 3.5 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Waverley Pharma Inc. 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?
- Waverley Pharma Inc, NDC labeler code 72338. 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/1.4mL | 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 |
Other NDCs under ANDA 211898
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 3.5 mg/3.5mL | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Somerset Therapeutics LLC | 70069-836 |