Cytarabine NDC 68083-343

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-343Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0343Add 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
68083-343-05	68083034305	5 VIAL, SINGLE-DOSE in 1 CARTON (68083-343-05) / 5 mL in 1 VIAL, SINGLE-DOSE (68083-343-01)Marketed from Dec 23, 2019

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): Cytarabine
Generic name (nonproprietary): cytarabine
Active ingredients: Cytarabine — 20 mg/mL
Dosage form: Injection, Solution
Route: Intrathecal, Intravenous, Subcutaneous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211937
Marketing start: Dec 23, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 68083-343_47628a16-dba0-4e55-ac61-70fc4d94730aSPL ID 47628a16-dba0-4e55-ac61-70fc4d94730aSPL set ID 7ab50348-ca78-46a5-aba6-c35b6b21fbfeRxCUI 1731355UNII 04079A1RDZ
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

N468083034305 followed by a unit qualifier and the quantity

Package 68083-0343-05. 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 Jul 13, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211937

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

FDA NDC Directory listings under ANDA 211937
Product	Strength	Form · route	Labeler	Product NDC
cytarabine	Cytarabine 20 mg/mL	Injection, SolutionIntrathecal, Intravenous, Subcutaneous	Sagent Pharmaceuticals	25021-229