Prescription drug · NDA
Thiola EC (Tiopronin) NDC 0178-0901
Tiopronin 300 mg/1 · Tablet, Delayed release · Oral · Mission Pharmacal Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0178-0901-90 | 00178090190 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0901-90)Marketed from Jun 28, 2019 |
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)
- Thiola EC
- Generic name (nonproprietary)
- tiopronin
- Active ingredients
- Tiopronin — 300 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Mission Pharmacal CompanyNDC labeler code 0178
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211843
- Marketing start
- Listing expires
- Other FDA classes
- Cystine Disulfide Reduction (Mechanism)N-substituted Glycines (Chemical structure)
- Identifiers
- Product ID 0178-0901_4098f871-874f-92ec-e063-6394a90af53fSPL ID 4098f871-874f-92ec-e063-6394a90af53fSPL set ID 20298a52-a194-a161-8632-d84b6f26e23cRxCUI 2178075, 2178077, 2178079, 2178081UNII C5W04GO61SUPC 0301780901908, 0301780902011
- 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
N400178090190followed by a unit qualifier and the quantityPackage 00178-0901-90. 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)
THIOLA EC is 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. THIOLA EC is 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.
About NDC 0178-0901
- What is NDC 0178-0901?
- 0178-0901 is the product NDC for Thiola EC (tiopronin), Tiopronin 300 mg/1 tablet, delayed release, listed with the FDA by Mission Pharmacal Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Thiola EC (Tiopronin).
- What is the active ingredient?
- Tiopronin.
- Who is the labeler?
- Mission Pharmacal Company, NDC labeler code 0178. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Thiola EC?
- 1 other product NDC are listed under this name. See all Thiola EC NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Thiola EC products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Thiola ECtiopronin | Tiopronin 100 mg/1 | Tablet, Delayed releaseOral | Mission Pharmacal Company | 0178-0902 | 00178-0902-01 |
Other NDCs under NDA 211843
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 |
|---|---|---|---|---|
| Thiola ECtiopronin | Tiopronin 100 mg/1 | Tablet, Delayed releaseOral | Mission Pharmacal Company | 0178-0902 |
| Tiopronin | Tiopronin 100 mg/1 | Tablet, Delayed releaseOral | BioComp Pharma, Inc. | 44523-054 |
| Tiopronin | Tiopronin 300 mg/1 | Tablet, Delayed releaseOral | BioComp Pharma, Inc. | 44523-055 |