tiopronin
- Product NDC
- 60219-2009
- 11-digit product format
- 602192009
- Labeler code
- 60219
- Product ID
- 60219-2009_98b9196d-4cc8-4ffe-8a45-8bced8f4284f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tiopronin
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA216278
- Marketing category
- ANDA
- Marketing start
- 2025-01-02
- 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 | 2178079 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60219-2009-9 | tiopronin | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60219-2009 | TIOPRONIN TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS NY LLC] | 6 | Current NDC, 1 package rows | 20230819_ce5b1f97-5b3c-40b6-b1c4-1d36025be1b8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60219-2009-9 | 60219200909 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (60219-2009-9) | 2025-01-02 | No | No | Historical |