What is NDC 68083-462?

68083-462 is the product NDC for Arsenic Trioxide, Arsenic trioxide 2 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 Arsenic Trioxide?

26 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Arsenic Trioxide NDC 68083-462 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-462Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0462Add 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
68083-462-10	6808304621068083046210	10 VIAL, SINGLE-DOSE in 1 CARTON (68083-462-10) / 6 mL in 1 VIAL, SINGLE-DOSE (68083-462-01)Marketed from Oct 7, 2021

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): Arsenic Trioxide
Generic name (nonproprietary): arsenic trioxide
Active ingredients: Arsenic trioxide — 2 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 215059
Marketing start: Oct 7, 2021
Listing expires: Dec 31, 2027
Identifiers: Product ID 68083-462_dbad2610-ef0d-4733-a28a-3428ff59f56aSPL ID dbad2610-ef0d-4733-a28a-3428ff59f56aSPL set ID 2cb52683-1e74-4831-a771-55a78536cfe5RxCUI 829926, 1992545UNII S7V92P67HO

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

N468083046210 followed by a unit qualifier and the quantity

Package 68083-0462-10. 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 Sep 12, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Arsenic trioxide injection is an arsenical indicated: For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. ( 1.2 ) 1.2 Relapsed or Refractory APL Arsenic trioxide injection is indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-462

What is NDC 68083-462?: 68083-462 is the product NDC for Arsenic Trioxide, Arsenic trioxide 2 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?: Arsenic Trioxide.
What is the active ingredient?: Arsenic trioxide.
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 Arsenic Trioxide?: 26 other product NDCs are listed under this name. See all Arsenic Trioxide 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 Arsenic Trioxide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Arsenic Trioxide	Arsenic trioxide 1 mg/mL	Injection, SolutionIntravenous	Sintetica US LLC	83090-009	83090-0009-0183090-0009-10
Arsenic Trioxide	Arsenic trioxide 2 mg/mL	Injection, SolutionIntravenous	Sintetica US LLC	83090-010	83090-0010-0183090-0010-10
Arsenic Trioxide	Arsenic trioxide 1 mg/mL	InjectionIntravenous	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc	23155-869	23155-0869-41
Arsenic Trioxide	Arsenic trioxide 2 mg/mL	InjectionIntravenous	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc	23155-870	23155-0870-41
Arsenic Trioxide	Arsenic trioxide 1 mg/mL	Injection, SolutionIntravenous	Orbicular Pharmaceutical Technologies Private Limited	81607-005	81607-0005-11
Arsenic Trioxide	Arsenic trioxide 2 mg/mL	Injection, SolutionIntravenous	Orbicular Pharmaceutical Technologies Private Limited	81607-006	81607-0006-07
Arsenic Trioxide	Arsenic trioxide 1 mg/mL	Injection, SolutionIntravenous	Novadoz Pharmaceuticals LLC	72205-171	72205-0171-07
Arsenic Trioxide	Arsenic trioxide 2 mg/2mL	Injection, SolutionIntravenous	Novadoz Pharmaceuticals LLC	72205-172	72205-0172-07
Arsenic Trioxide	Arsenic trioxide 1 mg/mL	Injection, SolutionIntravenous	Northstar Rx LLC	72603-339	72603-0339-10
Arsenic trioxide	Arsenic trioxide 1 mg/mL	Injection, SolutionIntravenous	Zydus Pharmaceuticals USA Inc.	70710-1895	70710-1895-06

All 27 Arsenic Trioxide NDCs

Other NDCs under ANDA 215059

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

FDA NDC Directory listings under ANDA 215059
Product	Strength	Form · route	Labeler	Product NDC
Arsenic Trioxide	Arsenic trioxide 1 mg/mL	InjectionIntravenous	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc	23155-869
Arsenic Trioxide	Arsenic trioxide 2 mg/mL	InjectionIntravenous	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc	23155-870
Arsenic Trioxide	Arsenic trioxide 1 mg/mL	InjectionIntravenous	Sagent Pharmaceuticals	25021-226
Arsenic Trioxide	Arsenic trioxide 2 mg/mL	InjectionIntravenous	Sagent Pharmaceuticals	25021-227
Arsenic Trioxide	Arsenic trioxide 1 mg/mL	InjectionIntravenous	Gland Pharma Limited	68083-535