What is NDC 0254-3035?

0254-3035 is the product NDC for Tiopronin, Tiopronin 300 mg/1 tablet, delayed release, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Par Health USA, LLC, NDC labeler code 0254. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tiopronin?

10 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tiopronin NDC 0254-3035 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0254-3035Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00254-3035Add 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
0254-3035-09	00254303509	90 TABLET, DELAYED RELEASE in 1 BOTTLE (0254-3035-09)Marketed from Jun 26, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Tiopronin
Generic name (nonproprietary): tiopronin
Active ingredients: Tiopronin — 300 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Par Health USA, LLCNDC labeler code 0254
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217219
Marketing start: Jun 26, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Cystine Disulfide Reduction (Mechanism)N-substituted Glycines (Chemical structure)
Identifiers: Product ID 0254-3035_b41fe359-c316-415d-86e0-b2376da66facSPL ID b41fe359-c316-415d-86e0-b2376da66facSPL set ID 5396b9fd-5385-44fd-a8ba-e56a46a33bc7RxCUI 2178075, 2178079UNII C5W04GO61SUPC 2307744035090, 0302543034307
Pharmacologic class: Reducing and Complexing Thiol

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

N400254303509 followed by a unit qualifier and the quantity

Package 00254-3035-09. 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 31, 2024.

Indications (excerpt from the label)

Tiopronin delayed-release tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Additional pediatric use information is approved for Mission Pharmacal Company’s Thiola EC (tiopronin) delayed release tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information. Tiopronin delayed-release tablets are a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0254-3035

What is NDC 0254-3035?: 0254-3035 is the product NDC for Tiopronin, Tiopronin 300 mg/1 tablet, delayed release, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tiopronin.
What is the active ingredient?: Tiopronin.
Who is the labeler?: Par Health USA, LLC, NDC labeler code 0254. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tiopronin?: 10 other product NDCs are listed under this name. See all Tiopronin 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 Tiopronin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tiopronin	Tiopronin 100 mg/1	Tablet, Sugar coatedOral	BioComp Pharma, Inc.	44523-053	44523-0053-01
tiopronin	Tiopronin 300 mg/1	Tablet, Delayed releaseOral	Amneal Pharmaceuticals NY LLC	60219-2009	60219-2009-09
Tiopronin	Tiopronin 100 mg/1	Tablet, Delayed releaseOral	BioComp Pharma, Inc.	44523-054	44523-0054-01
Tiopronin	Tiopronin 300 mg/1	Tablet, Delayed releaseOral	BioComp Pharma, Inc.	44523-055	44523-0055-01
Tiopronin	Tiopronin 300 mg/1	Tablet, Delayed releaseOral	Teva Pharmaceuticals, Inc.	0480-7824	00480-7824-98
Tiopronin	Tiopronin 100 mg/1	Tablet, Delayed releaseOral	Teva Pharmaceuticals, Inc.	0480-9227	00480-9227-55
Tiopronin	Tiopronin 100 mg/1	Tablet, Delayed releaseOral	Par Health USA, LLC	0254-3034	00254-3034-30
Tiopronin	Tiopronin 100 mg/1	Tablet, Delayed releaseOral	Torrent Pharmaceuticals Limited	13668-691	13668-0691-03
Tiopronin	Tiopronin 300 mg/1	Tablet, Delayed releaseOral	Torrent Pharmaceuticals Limited	13668-692	13668-0692-90
Tiopronin	Tiopronin 100 mg/1	Tablet, Sugar coatedOral	Teva Pharmaceuticals USA, Inc.	0093-7909	00093-7909-01

Other NDCs under ANDA 217219

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

FDA NDC Directory listings under ANDA 217219
Product	Strength	Form · route	Labeler	Product NDC
Tiopronin	Tiopronin 100 mg/1	Tablet, Delayed releaseOral	Par Health USA, LLC	0254-3034