Tiopronin
- Product NDC
- 0480-9227
- 11-digit product format
- 004809227
- Labeler code
- 0480
- Product ID
- 0480-9227_53891a64-8014-4b0b-9f13-cfc3d90166b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tiopronin
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA216456
- Marketing category
- ANDA
- Marketing start
- 2024-10-08
- Substance
- TIOPRONIN
- Active strength
- 100 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 | 100 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 |
|---|
| 0480-9227-55 | Tiopronin | 300 in 1 BOTTLE | TABLET, DELAYED RELEASE | 300 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-9227 | TIOPRONIN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS, INC.] | 4 | Current NDC, 1 package rows | 20241011_749257d9-a519-4b10-9058-7fe3f301cdd2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0480-9227-55 | 00480922755 | 300 TABLET, DELAYED RELEASE in 1 BOTTLE (0480-9227-55) | 2024-10-08 | No | No | Current |