gemcitabine (gemcitabine hydrochloride) NDC 25021-235

NDC codes

FDA NDC Directory

Product NDC (as listed)25021-235Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25021-0235Add 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
25021-235-50	25021023550	1 VIAL in 1 CARTON (25021-235-50) / 25 mL in 1 VIALMarketed from Dec 29, 2014
25021-235-51	25021023551	10 VIAL in 1 CARTON (25021-235-51) / 25 mL in 1 VIALMarketed from Dec 15, 2022

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 hydrochloride
Active ingredients: Gemcitabine hydrochloride — 1 g/25mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Sagent Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202485
Marketing start: Dec 29, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 25021-235_95123b19-2847-4cb8-8736-ecca1399bb81SPL ID 95123b19-2847-4cb8-8736-ecca1399bb81
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

N425021023550 followed by a unit qualifier and the quantity

Package 25021-0235-50. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 202485

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

FDA NDC Directory listings under ANDA 202485
Product	Strength	Form · route	Labeler	Product NDC
gemcitabinegemcitabine hydrochloride	Gemcitabine hydrochloride 200 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-234