NDC codes

FDA NDC Directory
Product NDC (as listed)72338-200Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72338-0200Add 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 NDC11-digit (billing)PackageCopy
72338-200-0172338020001723380200011 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.

How CPT relates to drug billing

NDC on a medical claim

N472338020001 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Bortezomib NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
BortezomibBortezomib 3.5 mg/1Injection, Powder, Lyophilized, For solutionIntravenous, SubcutaneousAvenacy, LLC83634-20883634-0208-10
BortezomibBortezomib 1 mg/1Injection, Powder, Lyophilized, For solutionIntravenous, SubcutaneousGland Pharma Limited68083-65068083-0650-01
BortezomibBortezomib 2.5 mg/1Injection, Powder, Lyophilized, For solutionIntravenous, SubcutaneousGland Pharma Limited68083-65168083-0651-01
BortezomibBortezomib 3.5 mg/1Injection, Powder, Lyophilized, For solutionIntravenous, SubcutaneousNingbo Shuangcheng Pharmaceutical Co., Ltd.75007-50175007-0501-3175007-0501-32
BortezomibBortezomib 3.5 mg/1Injection, Powder, Lyophilized, For solutionIntravenous, SubcutaneousSagent Pharmaceuticals25021-26225021-0262-10
BortezomibBortezomib 3.5 mg/3.5mLInjection, Powder, Lyophilized, For solutionIntravenous, SubcutaneousSomerset Therapeutics LLC70069-83670069-0836-01
BortezomibBortezomib 3.5 mg/1Injection, Powder, Lyophilized, For solutionIntravenous, SubcutaneousNorthStar RxLLC72603-27072603-0270-01
BortezomibBortezomib 3.5 mg/1.4mLInjectionIntravenous, SubcutaneousShilpa Medicare Limited63759-303263759-3032-01
BortezomibBortezomib 3.5 mg/1Injection, Powder, Lyophilized, For solutionIntravenous, SubcutaneousCamber Pharmaceuticals, Inc.31722-30331722-0303-31
BortezomibBortezomib 3.5 mg/3.5mLInjection, Powder, Lyophilized, For solutionIntravenous, SubcutaneousSintetica US LLC83090-00883090-0008-01

All 30 Bortezomib NDCs

Other NDCs under ANDA 211898

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

FDA NDC Directory listings under ANDA 211898
ProductStrengthForm · routeLabelerProduct NDC
BortezomibBortezomib 3.5 mg/3.5mLInjection, Powder, Lyophilized, For solutionIntravenous, SubcutaneousSomerset Therapeutics LLC70069-836

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