Prescription drug · ANDA
Granisetron Hydrochloride NDC 0143-9745
Granisetron hydrochloride 1 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9745-05 | 0014397450500143974505 | 5 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-05) / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01)Marketed from Dec 23, 2009 | |
| 0143-9745-10 | 0014397451000143974510 | 10 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-10) / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01)Marketed from Dec 23, 2009 |
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)
- Granisetron Hydrochloride
- Generic name (nonproprietary)
- granisetron hydrochloride
- Active ingredients
- Granisetron hydrochloride — 1 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078629
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0143-9745_3b366664-32e3-4d5c-b75c-0b764ffa31f6SPL ID 3b366664-32e3-4d5c-b75c-0b764ffa31f6SPL set ID e07862df-f324-4575-a1ef-f7e1cbab4c7aRxCUI 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
N400143974505followed by a unit qualifier and the quantityPackage 00143-9745-05. 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)
Granisetron Hydrochloride Injection, USP 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. Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT 3 ) receptor antagonist indicated for: Prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0143-9745
- What is NDC 0143-9745?
- 0143-9745 is the product NDC for Granisetron Hydrochloride, Granisetron hydrochloride 1 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Granisetron Hydrochloride.
- What is the active ingredient?
- Granisetron hydrochloride.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Granisetron Hydrochloride?
- 9 other product NDCs are listed under this name. See all Granisetron Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Granisetron Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Granisetron Hydrochloride | Granisetron hydrochloride 1 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-350 | 69452-0350-0169452-0350-1169452-0350-92 |
| Granisetron Hydrochloride | Granisetron hydrochloride .1 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-861 | — |
| Granisetron Hydrochloride | Granisetron hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-863 | 67457-0863-01 |
| Granisetron Hydrochloride | Granisetron hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-864 | 67457-0864-04 |
| Granisetron Hydrochloride | Granisetron hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-175 | 55150-0175-01 |
| Granisetron Hydrochloride | Granisetron hydrochloride 4 mg/4mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-176 | 55150-0176-04 |
| Granisetron Hydrochloride | Granisetron hydrochloride 1 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9744 | 00143-9744-10 |
| Granisetron Hydrochloride | Granisetron hydrochloride 1 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-735 | 51991-0735-2051991-0735-32 |
| Granisetron hydrochloride | Granisetron hydrochloride 1 mg/1 | Tablet, Film coatedOral | Natco Pharma Limited | 63850-0005 | 63850-0005-0163850-0005-02 |
Other NDCs under ANDA 078629
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 | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9744 |