Prescription drug · NDA
Gemcitabine NDC 0409-0183
Gemcitabine hydrochloride 38 mg/mL · Injection, Solution · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-0183-01 | 00409018301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0183-01) / 5.26 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 24, 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, Solution
- Route
- Intravenous
- Labeler
- Hospira, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 200795
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 0409-0183_3a284abb-8c57-47dc-a138-5a6e6ab92b05SPL ID 3a284abb-8c57-47dc-a138-5a6e6ab92b05SPL set ID dc02a23b-3ff9-4441-aa91-8e9e629a7315RxCUI 1720960, 1720975, 1720977UNII 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.
- NDC on a medical claim
N400409018301followed by a unit qualifier and the quantityPackage 00409-0183-01. 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 .
Indications (excerpt from the label)
Gemcitabine Injection 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 Injection in combination with carboplatin is indicated…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 200795
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Gemcitabine | Gemcitabine hydrochloride 38 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-0181 |
| Gemcitabine | Gemcitabine hydrochloride 38 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-0182 |
| Gemcitabine | Gemcitabine hydrochloride 38 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-0182 |
| Gemcitabine | Gemcitabine hydrochloride 38 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-0181 |