What is NDC 68083-386?

68083-386 is the product NDC for Clofarabine, Clofarabine 1 mg/mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Clofarabine?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clofarabine NDC 68083-386 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-386Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0386Add 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
68083-386-01	6808303860168083038601	1 VIAL, SINGLE-DOSE in 1 CARTON (68083-386-01) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 14, 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): Clofarabine
Generic name (nonproprietary): clofarabine
Active ingredients: Clofarabine — 1 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207831
Marketing start: Nov 14, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 68083-386_e35a63ca-af60-4142-a5af-37640734e820SPL ID e35a63ca-af60-4142-a5af-37640734e820SPL set ID b7d3a96e-0280-4f14-b921-795996f75950RxCUI 486419UNII 762RDY0Y2HUPC 0368083386016
Pharmacologic class: Nucleoside Metabolic 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

N468083038601 followed by a unit qualifier and the quantity

Package 68083-0386-01. 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 Nov 21, 2022.

Indications (excerpt from the label)

Clofarabine Injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. Clofarabine Injection is a nucleoside metabolic inhibitor indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-386

What is NDC 68083-386?: 68083-386 is the product NDC for Clofarabine, Clofarabine 1 mg/mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clofarabine.
What is the active ingredient?: Clofarabine.
Who is the labeler?: Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clofarabine?: 8 other product NDCs are listed under this name. See all Clofarabine 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 Clofarabine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clofarabine	Clofarabine 1 mg/mL	InjectionIntravenous	Novadoz Pharmaceuticals LLC	72205-394	72205-0394-01
Clofarabine	Clofarabine 1 mg/mL	InjectionIntravenous	Eugia US LLC	55150-326	55150-0326-01
Clofarabine	Clofarabine 1 mg/mL	InjectionIntravenous	Meitheal Pharmaceuticals Inc.	71288-128	71288-0128-20
Clofarabine	Clofarabine 1 mg/mL	InjectionIntravenous	Fosun Pharma USA Inc.	72266-108	72266-0108-01
Clofarabine	Clofarabine 1 mg/mL	InjectionIntravenous	Dr.Reddy's Laboratories Inc	43598-309	43598-0309-20
Clofarabine	Clofarabine 1 mg/mL	InjectionIntravenous	Amneal Pharmaceuticals LLC	70121-1236	70121-1236-01
Clofarabine	Clofarabine 1 mg/mL	InjectionIntravenous	Zydus Lifesciences Limited	49315-003	49315-0003-06
Clofarabine	Clofarabine 1 mg/mL	InjectionIntravenous	Fresenius Kabi USA, LLC	63323-572	63323-0572-70

Other NDCs under ANDA 207831

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

FDA NDC Directory listings under ANDA 207831
Product	Strength	Form · route	Labeler	Product NDC
Clofarabine	Clofarabine 1 mg/mL	InjectionIntravenous	Fosun Pharma USA Inc.	72266-108