Prescription drug · ANDA
Tiopronin NDC 13668-692
Tiopronin 300 mg/1 · Tablet, Delayed release · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-692-90 | 13668069290 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-692-90)Marketed from Jan 30, 2024 |
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 — 300 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- 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 13668-692_b56545da-a8ae-437a-9757-44862a6d95f0SPL ID b56545da-a8ae-437a-9757-44862a6d95f0SPL set ID ad750031-08ec-4d92-af2d-97a80c454e14RxCUI 2178075, 2178079UNII C5W04GO61SUPC 0313668692907, 0313668691030
- 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
N413668069290followed by a unit qualifier and the quantityPackage 13668-0692-90. 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 .
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.
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 |
|---|---|---|---|---|
| Venxxivatiopronin | Tiopronin 100 mg/1 | Tablet, Delayed releaseOral | Cycle Pharmaceuticals Ltd. | 70709-121 |
| Venxxivatiopronin | Tiopronin 300 mg/1 | Tablet, Delayed releaseOral | Cycle Pharmaceuticals Ltd. | 70709-123 |
| Tiopronin | Tiopronin 100 mg/1 | Tablet, Delayed releaseOral | Torrent Pharmaceuticals Limited | 13668-691 |