What is NDC 68001-572?

68001-572 is the product NDC for bendamustine hydrochloride, Bendamustine hydrochloride 100 mg/20mL injection, powder, lyophilized, for solution, listed with the FDA by BluePoint Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.

BluePoint Laboratories, NDC labeler code 68001. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

bendamustine hydrochloride NDC 68001-572

NDC codes

FDA NDC Directory

Product NDC (as listed)68001-572Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68001-0572Add 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
68001-572-41	6800105724168001057241	1 VIAL, SINGLE-DOSE in 1 CARTON (68001-572-41) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 15, 2023

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): bendamustine hydrochloride
Generic name (nonproprietary): bendamustine hydrochloride
Active ingredients: Bendamustine hydrochloride — 100 mg/20mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: BluePoint LaboratoriesNDC labeler code 68001
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205574
Marketing start: Sep 15, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 68001-572_14ca6252-d081-3bdf-e063-6394a90abb8dSPL ID 14ca6252-d081-3bdf-e063-6394a90abb8dSPL set ID 0df025d2-c093-427a-b599-f605e71fe835RxCUI 1805001, 1805007UNII 981Y8SX18MUPC 0368001572415, 0368007511418
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

N468001057241 followed by a unit qualifier and the quantity

Package 68001-0572-41. 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 Mar 29, 2024.

Indications (excerpt from the label)

Bendamustine hydrochloride for Injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) Bendamustine hydrochloride for Injection is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) Bendamustine hyd…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68001-572

What is NDC 68001-572?: 68001-572 is the product NDC for bendamustine hydrochloride, Bendamustine hydrochloride 100 mg/20mL injection, powder, lyophilized, for solution, listed with the FDA by BluePoint Laboratories. 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?: BluePoint Laboratories, NDC labeler code 68001. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bendamustine Hydrochloride	Bendamustine hydrochloride 100 mg/4mL	InjectionIntravenous	Avyxa Pharma, LLC	83831-183	83831-0183-04
Bendamustine Hydrochloride	Bendamustine hydrochloride 25 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-391	55150-0391-01
Bendamustine Hydrochloride	Bendamustine hydrochloride 100 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-392	55150-0392-01
Bendamustine Hydrochloride	Bendamustine hydrochloride 25 mg/mL	Injection, SolutionIntravenous	Apotex Corp	60505-6228	60505-6228-00
Bendamustine Hydrochloride	Bendamustine hydrochloride 100 mg/1	InjectionIntravenous	Baxter Healthcare Corporation	10019-079	10019-0079-01
bendamustine hydrochloride	Bendamustine hydrochloride 25 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Accord Healthcare, Inc.	16729-250	16729-0250-03
bendamustine hydrochloride	Bendamustine hydrochloride 100 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Accord Healthcare, Inc.	16729-251	16729-0251-05

Other NDCs under ANDA 205574

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

FDA NDC Directory listings under ANDA 205574
Product	Strength	Form · route	Labeler	Product NDC
bendamustine hydrochloride	Bendamustine hydrochloride 25 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Accord Healthcare, Inc.	16729-250
bendamustine hydrochloride	Bendamustine hydrochloride 100 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Accord Healthcare, Inc.	16729-251