What is NDC 63850-0005?

63850-0005 is the product NDC for Granisetron hydrochloride, Granisetron hydrochloride 1 mg/1 tablet, film coated, listed with the FDA by Natco Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Natco Pharma Limited, NDC labeler code 63850. 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 63850-0005

NDC codes

FDA NDC Directory

Product NDC (as listed)63850-0005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63850-0005Add 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
63850-0005-1	6385000050163850000501	10 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-1)Marketed from Jun 22, 2009
63850-0005-2	6385000050263850000502	2 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-2)Marketed from Jun 22, 2009

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Natco Pharma LimitedNDC labeler code 63850
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078969
Marketing start: Jun 22, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 63850-0005_67953305-4eb0-4b00-abae-716ac25c5bf9SPL ID 67953305-4eb0-4b00-abae-716ac25c5bf9SPL set ID d2be8de3-04fe-4e92-82b4-98d749b89596RxCUI 310599UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N463850000501 followed by a unit qualifier and the quantity

Package 63850-0005-01. 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 Oct 25, 2019.

Indications (excerpt from the label)

INDICATIONS AND USAGE Granisetron hydrochloride tablets USP are indicated for the prevention of: Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63850-0005

What is NDC 63850-0005?: 63850-0005 is the product NDC for Granisetron hydrochloride, Granisetron hydrochloride 1 mg/1 tablet, film coated, listed with the FDA by Natco Pharma Limited. 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?: Natco Pharma Limited, NDC labeler code 63850. 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	67457-863	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/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

Other NDCs under ANDA 078969

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

FDA NDC Directory listings under ANDA 078969
Product	Strength	Form · route	Labeler	Product NDC
Granisetron Hydrochloride	Granisetron hydrochloride 1 mg/1	TabletOral	Breckenridge Pharmaceutical, Inc.	51991-735