What is NDC 63187-636?

63187-636 is the product NDC for Ondansetron Hydrochloride, Ondansetron hydrochloride 4 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 8 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 63187-636

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-636Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0636Add 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
63187-636-01	6318706360163187063601	1 TABLET, FILM COATED in 1 BOTTLE (63187-636-01)Marketed from Sep 4, 2018
63187-636-03	6318706360363187063603	3 TABLET, FILM COATED in 1 BOTTLE (63187-636-03)Marketed from May 1, 2017
63187-636-06	6318706360663187063606	6 TABLET, FILM COATED in 1 BOTTLE (63187-636-06)Marketed from Aug 1, 2019
63187-636-10	6318706361063187063610	10 BLISTER PACK in 1 CARTON (63187-636-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 2, 2016
63187-636-12	6318706361263187063612	12 TABLET, FILM COATED in 1 BOTTLE (63187-636-12)Marketed from Sep 4, 2018
63187-636-15	6318706361563187063615	15 TABLET, FILM COATED in 1 BOTTLE (63187-636-15)Marketed from May 2, 2016
63187-636-20	6318706362063187063620	20 TABLET, FILM COATED in 1 BOTTLE (63187-636-20)Marketed from May 2, 2016
63187-636-30	6318706363063187063630	30 TABLET, FILM COATED in 1 BOTTLE (63187-636-30)Marketed from May 2, 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 — 4 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 63187-636_2996955e-2b6c-4702-8c4a-6ab17c9e6e87SPL ID 2996955e-2b6c-4702-8c4a-6ab17c9e6e87SPL set ID 381b44e7-a5a1-42ad-bcea-1ab4c82ff5d4RxCUI 198052UNII NMH84OZK2BUPC 0363187636302
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

N463187063601 followed by a unit qualifier and the quantity

Package 63187-0636-01. 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 Apr 1, 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 63187-636

What is NDC 63187-636?: 63187-636 is the product NDC for Ondansetron Hydrochloride, Ondansetron hydrochloride 4 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 8 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

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