Prescription drug · ANDA
Granisetron Hydrochloride NDC 55150-176
Granisetron hydrochloride 4 mg/4mL · Injection, Solution · Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-176-04 | 55150017604 | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-176-04) / 4 mL in 1 VIAL, MULTI-DOSEMarketed from Jul 6, 2016 |
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)
- Granisetron Hydrochloride
- Generic name (nonproprietary)
- granisetron hydrochloride
- Active ingredients
- Granisetron hydrochloride — 4 mg/4mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Eugia US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204238
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55150-176_4dc2ec1d-ed65-481b-bc48-fae589eae213SPL ID 4dc2ec1d-ed65-481b-bc48-fae589eae213SPL set ID 783e9d68-2371-4fd4-8d7a-a5e36f8718d0RxCUI 240912, 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.
- NDC on a medical claim
N455150017604followed by a unit qualifier and the quantityPackage 55150-0176-04. 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)
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 is …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204238
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 | Eugia US LLC | 55150-175 |