TIOPRONIN
- Product NDC
- 0254-3035
- 11-digit product format
- 002543035
- Labeler code
- 0254
- Product ID
- 0254-3035_44d74b79-7146-42ef-ace2-fa64cffeb041
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TIOPRONIN
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- ANDA217219
- Marketing category
- ANDA
- Marketing start
- 2024-06-26
- Substance
- TIOPRONIN
- Active strength
- 300 mg/1
- Pharmacologic classes
- Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TIOPRONIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIOPRONIN | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C5W04GO61S |
| Rxcui | 2178075, 2178079 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0254-3035-09 | TIOPRONIN | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0254-3035 | TIOPRONIN TABLET, DELAYED RELEASE [ENDO USA, INC.] | 7 | Current NDC, 1 package rows | 20250109_5396b9fd-5385-44fd-a8ba-e56a46a33bc7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0254-3035-09 | 00254303509 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0254-3035-09) | 2024-06-26 | No | No | Historical |