Tiopronin
- Product NDC
- 44523-055
- 11-digit product format
- 445230055
- Labeler code
- 44523
- Product ID
- 44523-055_36d7fad3-57c6-67e7-e063-6294a90ad7b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tiopronin
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- BioComp Pharma, Inc.
- Application
- NDA211843
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-12-05
- 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 |
|---|
| 44523-055-01 | Tiopronin | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44523-055 | TIOPRONIN TABLET, DELAYED RELEASE [BIO COMP PHARMA, INC.] | 1 | Current NDC, 1 package rows | 20241208_1f2eb1d6-faa6-e352-e063-6294a90a7fb5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 44523-055-01 | 44523005501 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-055-01) | 2024-12-05 | No | No | Historical |