NDC codes

FDA NDC Directory
Product NDC (as listed)60505-6228Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-6228Add 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
60505-6228-060505622800605056228001 VIAL, MULTI-DOSE in 1 CARTON (60505-6228-0) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Apr 26, 2023

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)
Bendamustine Hydrochloride
Generic name (nonproprietary)
bendamustine hydrochloride
Active ingredients
Bendamustine hydrochloride — 25 mg/mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
Apotex CorpNDC labeler code 60505
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 215033
Marketing start
Listing expires
Other FDA classes
Alkylating Activity (Mechanism)
Identifiers
Product ID 60505-6228_75bee9ee-7dde-ac1b-47c0-05f247c7bee1SPL ID 75bee9ee-7dde-ac1b-47c0-05f247c7bee1SPL set ID 085dd54c-4212-d879-afef-ee52732a48c0RxCUI 1726097UNII 981Y8SX18M
Pharmacologic class
Alkylating Drug

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

N460505622800 followed by a unit qualifier and the quantity

Package 60505-6228-00. 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)

Non-Hodgkin Lymphoma (NHL) Bendamustine hydrochloride injection is indicated for the treatment of adult patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendamustine hydrochloride injection is an alkylating drug indicated for treatment of adult patients with: • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60505-6228

What is NDC 60505-6228?
60505-6228 is the product NDC for Bendamustine Hydrochloride, Bendamustine hydrochloride 25 mg/mL injection, solution, listed with the FDA by Apotex Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Bendamustine Hydrochloride.
What is the active ingredient?
Bendamustine hydrochloride.
Who is the labeler?
Apotex Corp, NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bendamustine Hydrochloride?
7 other product NDCs are listed under this name. See all Bendamustine Hydrochloride 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 Bendamustine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Bendamustine HydrochlorideBendamustine hydrochloride 100 mg/4mLInjectionIntravenousAvyxa Pharma, LLC83831-18383831-0183-04
bendamustine hydrochlorideBendamustine hydrochloride 100 mg/20mLInjection, Powder, Lyophilized, For solutionIntravenousBluePoint Laboratories68001-57268001-0572-41
Bendamustine HydrochlorideBendamustine hydrochloride 25 mg/5mLInjection, Powder, Lyophilized, For solutionIntravenousEugia US LLC55150-39155150-0391-01
Bendamustine HydrochlorideBendamustine hydrochloride 100 mg/20mLInjection, Powder, Lyophilized, For solutionIntravenousEugia US LLC55150-39255150-0392-01
Bendamustine HydrochlorideBendamustine hydrochloride 100 mg/1InjectionIntravenousBaxter Healthcare Corporation10019-07910019-0079-01
bendamustine hydrochlorideBendamustine hydrochloride 25 mg/5mLInjection, Powder, Lyophilized, For solutionIntravenousAccord Healthcare, Inc.16729-25016729-0250-03
bendamustine hydrochlorideBendamustine hydrochloride 100 mg/20mLInjection, Powder, Lyophilized, For solutionIntravenousAccord Healthcare, Inc.16729-25116729-0251-05

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