Gemcitabine NDC 63323-125

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-125Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0125Add 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
63323-125-94	63323012594	1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-94) / 25 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 26, 2011

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): Gemcitabine
Generic name (nonproprietary): gemcitabine
Active ingredients: Gemcitabine hydrochloride — 1 g/25mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090799
Marketing start: Jul 26, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 63323-125_4c447f74-d06c-459b-ba63-6b72aaf4fd2eSPL ID 4c447f74-d06c-459b-ba63-6b72aaf4fd2eSPL set ID d1f3951c-d13f-4662-ad4b-ecfc07f59104RxCUI 1719000, 1719003UNII U347PV74ILUPC 0363323125943, 0363323102944
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

N463323012594 followed by a unit qualifier and the quantity

Package 63323-0125-94. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.