What is NDC 68682-938?

68682-938 is the product NDC for Tolcapone, Tolcapone 100 mg/1 tablet, film coated, listed with the FDA by Oceanside Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

Oceanside Pharmaceuticals, NDC labeler code 68682. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tolcapone?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tolcapone NDC 68682-938 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68682-938Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68682-0938Add 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
68682-938-90	6868209389068682093890	90 TABLET, FILM COATED in 1 BOTTLE (68682-938-90)Marketed from Jul 27, 2004

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): Tolcapone
Generic name (nonproprietary): tolcapone
Active ingredients: Tolcapone — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Oceanside PharmaceuticalsNDC labeler code 68682
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020697
Marketing start: Jul 27, 2004
Listing expires: Dec 31, 2027
Other FDA classes: Catechol O-Methyltransferase Inhibitors (Mechanism)
Identifiers: Product ID 68682-938_9ec63a14-0b6a-47eb-9258-19b6e3cb5b25SPL ID 9ec63a14-0b6a-47eb-9258-19b6e3cb5b25SPL set ID dd367eec-359a-4065-b5c3-7c0107c823feRxCUI 200220UNII CIF6334OLYUPC 0368682938906
Pharmacologic class: Catechol-O-Methyltransferase Inhibitor

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

N468682093890 followed by a unit qualifier and the quantity

Package 68682-0938-90. 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 1, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS: Tolcapone tablets is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Because of the risk of potentially fatal, acute fulminant liver failure, Tolcapone tablets should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies. Because of the risk of liver injury and because Tolcapone tablets, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of init…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68682-938

What is NDC 68682-938?: 68682-938 is the product NDC for Tolcapone, Tolcapone 100 mg/1 tablet, film coated, listed with the FDA by Oceanside Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tolcapone.
What is the active ingredient?: Tolcapone.
Who is the labeler?: Oceanside Pharmaceuticals, NDC labeler code 68682. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tolcapone?: 1 other product NDC are listed under this name. See all Tolcapone 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 Tolcapone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tolcapone	Tolcapone 100 mg/1	TabletOral	Ingenus Pharmaceuticals, LLC	50742-193	50742-0193-90

Other NDCs under NDA 020697

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

FDA NDC Directory listings under NDA 020697
Product	Strength	Form · route	Labeler	Product NDC
Tasmartolcapone	Tolcapone 100 mg/1	Tablet, Film coatedOral	Bausch Health US LLC	0187-0938