What is NDC 63187-709?

63187-709 is the product NDC for Ondansetron Hydrochloride, Ondansetron hydrochloride 8 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ondansetron Hydrochloride?

76 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ondansetron Hydrochloride NDC 63187-709

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-709Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0709Add 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
63187-709-06	6318707090663187070906	6 TABLET, FILM COATED in 1 BOTTLE (63187-709-06)Marketed from Mar 1, 2019
63187-709-10	6318707091063187070910	10 TABLET, FILM COATED in 1 BOTTLE (63187-709-10)Marketed from Jun 1, 2016
63187-709-15	6318707091563187070915	15 TABLET, FILM COATED in 1 BOTTLE (63187-709-15)Marketed from Jun 1, 2016
63187-709-20	6318707092063187070920	20 TABLET, FILM COATED in 1 BOTTLE (63187-709-20)Marketed from Jun 1, 2016
63187-709-30	6318707093063187070930	30 TABLET, FILM COATED in 1 BOTTLE (63187-709-30)Marketed from Jun 1, 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): Ondansetron Hydrochloride
Generic name (nonproprietary): ondansetron hydrochloride
Active ingredients: Ondansetron hydrochloride — 8 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078539
Marketing start: Jul 31, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 63187-709_f4c58aa3-ca42-4627-b267-35e3894f69bbSPL ID f4c58aa3-ca42-4627-b267-35e3894f69bbSPL set ID 69ed01b7-a94e-4946-a044-a9f8c37616ecRxCUI 312086UNII NMH84OZK2BUPC 0363187709303
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

N463187070906 followed by a unit qualifier and the quantity

Package 63187-0709-06. 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 May 2, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE 1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m 2 . 2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In pa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-709

What is NDC 63187-709?: 63187-709 is the product NDC for Ondansetron Hydrochloride, Ondansetron hydrochloride 8 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ondansetron Hydrochloride.
What is the active ingredient?: Ondansetron hydrochloride.
Who is the labeler?: Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ondansetron Hydrochloride?: 76 other product NDCs are listed under this name. See all Ondansetron 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 Ondansetron Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
ondansetron hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Ipca Laboratories Limited	83980-017	83980-0017-1083980-0017-1383980-0017-97
ondansetron hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Ipca Laboratories Limited	83980-018	83980-0018-1083980-0018-1383980-0018-97
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-878	60760-0878-10
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-088	87441-0088-01
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-064	87441-0064-01
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1242	67046-1242-03
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Quality Care Products, LLC	83008-074	83008-0074-2083008-0074-30
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4145	70518-4145-0070518-4145-0170518-4145-02+3 more
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8651	68788-8651-0168788-8651-0268788-8651-03+2 more
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8582	68788-8582-0168788-8582-0268788-8582-03+2 more

All 77 Ondansetron Hydrochloride NDCs

Other NDCs under ANDA 078539

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

FDA NDC Directory listings under ANDA 078539
Product	Strength	Form · route	Labeler	Product NDC
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8651
Ondansetron	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	PharmPak, Inc.	54348-819
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-119
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Pharmpak, Inc.	54348-821
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-878
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-9368
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-9402
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-076
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-075
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-792
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3511
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-034
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	QPharma, Inc.	42708-179
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1585
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-744
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1596
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4145
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6342
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-813
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-1562

Showing 20 of 40.