What is NDC 44523-053?

44523-053 is the product NDC for Tiopronin, Tiopronin 100 mg/1 tablet, sugar coated, listed with the FDA by BioComp Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

BioComp Pharma, Inc., NDC labeler code 44523. 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 44523-053 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)44523-053Labeler and product segments. Claims need a package NDC.

Product NDC at billing width44523-0053Add 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
44523-053-01	44523005301	100 TABLET, SUGAR COATED in 1 BOTTLE (44523-053-01)Marketed from Sep 1, 2026

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): Tiopronin
Generic name (nonproprietary): tiopronin
Active ingredients: Tiopronin — 100 mg/1
Dosage form: Tablet, Sugar coated
Route: Oral
Labeler: BioComp Pharma, Inc.NDC labeler code 44523
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 019569
Marketing start: Sep 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Cystine Disulfide Reduction (Mechanism)N-substituted Glycines (Chemical structure)
Identifiers: Product ID 44523-053_59e06801-0ef4-29f2-e063-6294a90a4368SPL ID 59e06801-0ef4-29f2-e063-6294a90a4368SPL set ID 59e06801-0ef3-29f2-e063-6294a90a4368RxCUI 198287UNII C5W04GO61SUPC 0344523053014
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

N444523005301 followed by a unit qualifier and the quantity

Package 44523-0053-01. 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 Aug 25, 2026.

Indications (excerpt from the label)

Tiopronin 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 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone. Tiopronin Tablets are a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 44523-053

What is NDC 44523-053?: 44523-053 is the product NDC for Tiopronin, Tiopronin 100 mg/1 tablet, sugar coated, listed with the FDA by BioComp Pharma, Inc.. 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?: BioComp Pharma, Inc., NDC labeler code 44523. 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 300 mg/1	Tablet, Delayed releaseOral	Amneal Pharmaceuticals NY LLC	60219-2009	60219-2009-09
Tiopronin	Tiopronin 300 mg/1	Tablet, Delayed releaseOral	BioComp Pharma, Inc.	44523-055	44523-0055-01
Tiopronin	Tiopronin 100 mg/1	Tablet, Delayed releaseOral	BioComp Pharma, Inc.	44523-054	44523-0054-01
Tiopronin	Tiopronin 100 mg/1	Tablet, Delayed releaseOral	Teva Pharmaceuticals, Inc.	0480-9227	00480-9227-55
Tiopronin	Tiopronin 300 mg/1	Tablet, Delayed releaseOral	Teva Pharmaceuticals, Inc.	0480-7824	00480-7824-98
Tiopronin	Tiopronin 100 mg/1	Tablet, Delayed releaseOral	Par Health USA, LLC	0254-3034	00254-3034-30
Tiopronin	Tiopronin 300 mg/1	Tablet, Delayed releaseOral	Par Health USA, LLC	0254-3035	00254-3035-09
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 NDA 019569

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

FDA NDC Directory listings under NDA 019569
Product	Strength	Form · route	Labeler	Product NDC
Thiolatiopronin	Tiopronin 100 mg/1	Tablet, Sugar coatedOral	Mission Pharmacal Company	0178-0900