Prescription drug · ANDA
Granisetron Hydrochloride NDC 67457-861
Granisetron hydrochloride .1 mg/mL · Injection, Solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Granisetron Hydrochloride
- Generic name (nonproprietary)
- granisetron hydrochloride
- Active ingredients
- Granisetron hydrochloride — .1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091136
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 67457-861_9baf50f5-8a78-4532-af34-57f5d0c74daeSPL ID 9baf50f5-8a78-4532-af34-57f5d0c74daeSPL set ID 8d88adba-7f5e-4e97-84b3-6ca8ec98c023RxCUI 240912, 543218, 1734399UNII 318F6L70J8
- Pharmacologic class
- Serotonin-3 Receptor Antagonist
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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Granisetron hydrochloride injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated for: • The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. • The prevention and treatment of postoperative nausea and vomiting in adults. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided during the postoperative period, granisetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091136
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 |
|---|---|---|---|---|
| Granisetron Hydrochloride | Granisetron hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-863 |