Prescription drug · ANDA
Gemcitabine hydrochloride NDC 82511-009
Gemcitabine hydrochloride 1 g/25mL · Injection, Powder, Lyophilized, For solution · Intravenous · Teyro Labs Private Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82511-009-10 | 82511000910 | 1 VIAL, SINGLE-USE in 1 CARTON (82511-009-10) / 25 mL in 1 VIAL, SINGLE-USEMarketed from Aug 8, 2024 |
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 hydrochloride
- Generic name (nonproprietary)
- gemcitabine hydrochloride
- Active ingredients
- Gemcitabine hydrochloride — 1 g/25mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Teyro Labs Private Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078759
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 82511-009_2b407956-8a90-221c-e063-6394a90a0057SPL ID 2b407956-8a90-221c-e063-6394a90a0057SPL set ID a6ddaa2f-4c17-430f-a7cd-96b6662923f6RxCUI 1719000, 1719003UNII U347PV74ILUPC 0382511008202
- 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
N482511000910followed by a unit qualifier and the quantityPackage 82511-0009-10. 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 for 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 for Injection in combination with carboplatin is indicate…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078759
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 hydrochloride | Gemcitabine hydrochloride 200 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Teyro Labs Private Limited | 82511-008 |