Bortezomib NDC 43598-426

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-426Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0426Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
43598-426-60	43598042660	1 VIAL, SINGLE-DOSE in 1 CARTON (43598-426-60) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Jul 26, 2022

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: Dr.Reddy's Laboratories, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202963
Marketing start: Jul 26, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Proteasome Inhibitors (Mechanism)
Identifiers: Product ID 43598-426_1db2c9f6-afec-c8c2-f92d-4036e6aab6dfSPL ID 1db2c9f6-afec-c8c2-f92d-4036e6aab6dfSPL set ID 664bee24-7af2-2099-ac99-5dd71a1e5a14RxCUI 402243UNII 69G8BD63PPUPC 0343598426600
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.

How CPT relates to drug billing

NDC on a medical claim

N443598042660 followed by a unit qualifier and the quantity

Package 43598-0426-60. 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 May 17, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202963

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202963
Product	Strength	Form · route	Labeler	Product NDC
Bortezomib	Bortezomib 3.5 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous	NorthStar RxLLC	72603-270