Prescription drug · ANDA
Gemcitabine NDC 25021-239
Gemcitabine hydrochloride 38 mg/mL · Injection, Solution · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-239-05 | 25021023905 | 1 VIAL in 1 CARTON (25021-239-05) / 5.26 mL in 1 VIALMarketed from Jan 15, 2019 | |
| 25021-239-26 | 25021023926 | 1 VIAL in 1 CARTON (25021-239-26) / 26.3 mL in 1 VIALMarketed from Jan 15, 2019 | |
| 25021-239-52 | 25021023952 | 1 VIAL in 1 CARTON (25021-239-52) / 52.6 mL in 1 VIALMarketed from Jan 15, 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)
- Gemcitabine
- Generic name (nonproprietary)
- gemcitabine
- Active ingredients
- Gemcitabine hydrochloride — 38 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209077
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 25021-239_adf9b715-8cef-4a0d-ba30-d948b2b04272SPL ID adf9b715-8cef-4a0d-ba30-d948b2b04272SPL set ID 22af3507-4b4f-4cad-9d61-89ffc4aabbc7RxCUI 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
N425021023905followed by a unit qualifier and the quantityPackage 25021-0239-05. 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 .
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 for the…
Excerpt only. Read the full label for complete information.