Cystagon
- Product NDC
- 0378-9045
- 11-digit product format
- 003789045
- Labeler code
- 0378
- Product ID
- 0378-9045_29dfd298-96ed-4a5f-a573-b24f5ffa618b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cysteamine bitartrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA020392
- Marketing category
- NDA
- Marketing start
- 2005-04-11
- Substance
- CYSTEAMINE BITARTRATE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Cystine Depleting Agent [EPC], Cystine Disulfide Reduction [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cystagon
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYSTEAMINE BITARTRATE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QO84GZ3TST |
| Rxcui | 209788, 209789, 309636, 309637 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-9045-05 | Cystagon | 500 in 1 BOTTLE, PLASTIC | CAPSULE | 500 | | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-9045 | CYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.] | 13 | Current NDC, Legacy NDC, 1 package rows | 20241215_f495b76d-96c6-48e5-8fa3-30a4336628eb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-9045-05 | 00378904505 | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05) | 500 capsule | 2005-04-11 | 2030-01-01 | No | No | Current |