Prescription drug · ANDA
Venxxiva (Tiopronin) NDC 70709-121
Tiopronin 100 mg/1 · Tablet, Delayed release · Oral · Cycle Pharmaceuticals Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70709-121-30 | 7070901213070709012130 | 300 TABLET, DELAYED RELEASE in 1 BOTTLE (70709-121-30)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 — 100 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Cycle Pharmaceuticals Ltd.NDC labeler code 70709
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216990
- Marketing start
- Listing expires
- Other FDA classes
- Cystine Disulfide Reduction (Mechanism)N-substituted Glycines (Chemical structure)
- Identifiers
- Product ID 70709-121_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
N470709012130followed by a unit qualifier and the quantityPackage 70709-0121-30. 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 .
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.
About NDC 70709-121
- What is NDC 70709-121?
- 70709-121 is the product NDC for Venxxiva (tiopronin), Tiopronin 100 mg/1 tablet, delayed release, listed with the FDA by Cycle Pharmaceuticals Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Venxxiva (Tiopronin).
- What is the active ingredient?
- Tiopronin.
- Who is the labeler?
- Cycle Pharmaceuticals Ltd., NDC labeler code 70709. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Venxxiva?
- 1 other product NDC are listed under this name. See all Venxxiva NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Venxxiva products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Venxxivatiopronin | Tiopronin 300 mg/1 | Tablet, Delayed releaseOral | Cycle Pharmaceuticals Ltd. | 70709-123 | 70709-0123-90 |
Other NDCs under ANDA 216990
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tiopronin | Tiopronin 100 mg/1 | Tablet, Delayed releaseOral | Torrent Pharmaceuticals Limited | 13668-691 |
| Tiopronin | Tiopronin 300 mg/1 | Tablet, Delayed releaseOral | Torrent Pharmaceuticals Limited | 13668-692 |
| Venxxivatiopronin | Tiopronin 300 mg/1 | Tablet, Delayed releaseOral | Cycle Pharmaceuticals Ltd. | 70709-123 |