What is NDC 50742-193?

50742-193 is the product NDC for Tolcapone, Tolcapone 100 mg/1 tablet, listed with the FDA by Ingenus Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Ingenus Pharmaceuticals, LLC, NDC labeler code 50742. 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 50742-193 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50742-193Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50742-0193Add 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
50742-193-90	50742019390	90 TABLET in 1 BOTTLE (50742-193-90)Marketed from Aug 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): Tolcapone
Generic name (nonproprietary): tolcapone
Active ingredients: Tolcapone — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Ingenus Pharmaceuticals, LLCNDC labeler code 50742
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208937
Marketing start: Aug 21, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Catechol O-Methyltransferase Inhibitors (Mechanism)
Identifiers: Product ID 50742-193_b0eeccbf-775d-4ff7-805c-cc176f965198SPL ID b0eeccbf-775d-4ff7-805c-cc176f965198SPL set ID d94891be-2fef-4e39-8e35-ab7afe93e78eRxCUI 200220UNII CIF6334OLY
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

N450742019390 followed by a unit qualifier and the quantity

Package 50742-0193-90. 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 Sep 11, 2019. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Tolcapone tablets, USP 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, USP 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, USP, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50742-193

What is NDC 50742-193?: 50742-193 is the product NDC for Tolcapone, Tolcapone 100 mg/1 tablet, listed with the FDA by Ingenus Pharmaceuticals, LLC. 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?: Ingenus Pharmaceuticals, LLC, NDC labeler code 50742. 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	Tablet, Film coatedOral	Oceanside Pharmaceuticals	68682-938	68682-0938-90