What is NDC 67457-863?

67457-863 is the product NDC for Granisetron Hydrochloride, Granisetron hydrochloride 1 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Institutional LLC, NDC labeler code 67457. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Granisetron Hydrochloride NDC 67457-863

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-863Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0863Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
67457-863-01	6745708630167457086301	1 VIAL in 1 CARTON (67457-863-01) / 1 mL in 1 VIALMarketed from Mar 21, 2018

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 — 1 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Mylan Institutional LLCNDC labeler code 67457
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091136
Marketing start: Mar 21, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 67457-863_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.

How CPT relates to drug billing

NDC on a medical claim

N467457086301 followed by a unit qualifier and the quantity

Package 67457-0863-01. 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 Aug 31, 2017.

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.

Full label on DailyMed (opens in a new tab)

About NDC 67457-863

What is NDC 67457-863?: 67457-863 is the product NDC for Granisetron Hydrochloride, Granisetron hydrochloride 1 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, 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?: Mylan Institutional LLC, NDC labeler code 67457. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Granisetron Hydrochloride NDCs
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	67457-864	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/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9745	00143-9745-0500143-9745-10
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 091136

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 091136
Product	Strength	Form · route	Labeler	Product NDC
Granisetron Hydrochloride	Granisetron hydrochloride .1 mg/mL	Injection, SolutionIntravenous	Mylan Institutional LLC	67457-861