Venxxiva (tiopronin) NDC 70709-123

NDC codes

FDA NDC Directory

Product NDC (as listed)70709-123Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70709-0123Add 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
70709-123-90	70709012390	90 TABLET, DELAYED RELEASE in 1 BOTTLE (70709-123-90)Marketed from Jan 22, 2025

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): Venxxiva
Generic name (nonproprietary): tiopronin
Active ingredients: Tiopronin — 300 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Cycle Pharmaceuticals Ltd.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216990
Marketing start: Jan 22, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Cystine Disulfide Reduction (Mechanism)N-substituted Glycines (Chemical structure)
Identifiers: Product ID 70709-123_c8eeb4d4-9718-41ba-b4fe-3d645fd60a20SPL ID c8eeb4d4-9718-41ba-b4fe-3d645fd60a20SPL set ID 02e24443-04c6-4b98-a395-49aec4a468deRxCUI 2178075, 2178079, 2702682, 2702684UNII C5W04GO61SUPC 0370709123905, 0370709121307
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

N470709012390 followed by a unit qualifier and the quantity

Package 70709-0123-90. 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 Dec 22, 2025.

Indications (excerpt from the label)

VENXXIVA is 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. VENXXIVA is a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone f…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216990

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

FDA NDC Directory listings under ANDA 216990
Product	Strength	Form · route	Labeler	Product NDC
Venxxivatiopronin	Tiopronin 100 mg/1	Tablet, Delayed releaseOral	Cycle Pharmaceuticals Ltd.	70709-121
Tiopronin	Tiopronin 300 mg/1	Tablet, Delayed releaseOral	Torrent Pharmaceuticals Limited	13668-692
Tiopronin	Tiopronin 100 mg/1	Tablet, Delayed releaseOral	Torrent Pharmaceuticals Limited	13668-691