Prescription drug · ANDA
Tiopronin NDC 0093-7909
Tiopronin 100 mg/1 · Tablet, Sugar coated · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-7909-01 | 00093790901 | 100 TABLET, SUGAR COATED in 1 BOTTLE (0093-7909-01)Marketed from May 17, 2021 |
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)
- Tiopronin
- Generic name (nonproprietary)
- tiopronin
- Active ingredients
- Tiopronin — 100 mg/1
- Dosage form
- Tablet, Sugar coated
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214326
- Marketing start
- Listing expires
- Other FDA classes
- Cystine Disulfide Reduction (Mechanism)N-substituted Glycines (Chemical structure)
- Identifiers
- Product ID 0093-7909_f2fc3b85-ad95-4e79-b523-5dab8ff96c96SPL ID f2fc3b85-ad95-4e79-b523-5dab8ff96c96SPL set ID 8dee6eff-0ec1-4fe7-8d27-18cdc6cf54b9RxCUI 198287UNII C5W04GO61SUPC 0300937909019
- 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
N400093790901followed by a unit qualifier and the quantityPackage 00093-7909-01. 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 .
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 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 (tiopronin) tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information. Tiopronin is a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation…
Excerpt only. Read the full label for complete information.
About NDC 0093-7909
- What is NDC 0093-7909?
- 0093-7909 is the product NDC for Tiopronin, Tiopronin 100 mg/1 tablet, sugar coated, listed with the FDA by Teva Pharmaceuticals USA, 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?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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.
Related NDCs: other Tiopronin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tiopronin | Tiopronin 100 mg/1 | Tablet, Sugar coatedOral | BioComp Pharma, Inc. | 44523-053 | 44523-0053-01 |
| tiopronin | Tiopronin 300 mg/1 | Tablet, Delayed releaseOral | Amneal Pharmaceuticals NY LLC | 60219-2009 | 60219-2009-09 |
| Tiopronin | Tiopronin 100 mg/1 | Tablet, Delayed releaseOral | BioComp Pharma, Inc. | 44523-054 | 44523-0054-01 |
| Tiopronin | Tiopronin 300 mg/1 | Tablet, Delayed releaseOral | BioComp Pharma, Inc. | 44523-055 | 44523-0055-01 |
| Tiopronin | Tiopronin 300 mg/1 | Tablet, Delayed releaseOral | Teva Pharmaceuticals, Inc. | 0480-7824 | 00480-7824-98 |
| Tiopronin | Tiopronin 100 mg/1 | Tablet, Delayed releaseOral | Teva Pharmaceuticals, Inc. | 0480-9227 | 00480-9227-55 |
| 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 |