Gemcitabine NDC 0409-0185

NDC codes

FDA NDC Directory

Product NDC (as listed)0409-0185Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00409-0185Add 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
0409-0185-01	00409018501	1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0185-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 26, 2011

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 38 mg/mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Hospira, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078339
Marketing start: Jul 26, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 0409-0185_111b13bb-6793-4b33-b845-0dc9b46837deSPL ID 111b13bb-6793-4b33-b845-0dc9b46837deSPL set ID d16907e7-a8c8-4039-ace4-cf4e24ba68c0RxCUI 1719000, 1719003UNII U347PV74IL
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

N400409018501 followed by a unit qualifier and the quantity

Package 00409-0185-01. 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 Aug 16, 2024.

Indications (excerpt from the label)

Gemcitabine is a nucleoside metabolic inhibitor indicated: • in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) • in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) • in combination with cisplatin, for the treatment of non-small cell lung cancer. ( 1.3 ) • as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine in combination with carboplatin is indicated for the treatment …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078339

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

FDA NDC Directory listings under ANDA 078339
Product	Strength	Form · route	Labeler	Product NDC
Gemcitabine	Gemcitabine hydrochloride 38 mg/mL	Injection, Powder, Lyophilized, For solutionIntravenous	Hospira, Inc.	0409-0186