CYSTADROPS
- Product NDC
- 55292-410
- 11-digit product format
- 552920410
- Labeler code
- 55292
- Product ID
- 55292-410_34dba967-28b4-4fc8-876d-2e30d32a0f95
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cysteamine hydrochloride
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- RECORDATI RARE DISEASES, INC.
- Application
- NDA211302
- Marketing category
- NDA
- Marketing start
- 2020-08-19
- Substance
- CYSTEAMINE HYDROCHLORIDE
- Active strength
- 3.5 mg/mL
- 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
- CYSTADROPS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYSTEAMINE HYDROCHLORIDE | 3.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IF1B771SVB |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55292-410-05 | CYSTADROPS | 1 in 1 BOX | SOLUTION | 1 | | 5 |
| 55292-410-05 | CYSTADROPS | 5 mL in 1 BOTTLE, GLASS | SOLUTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55292-410 | CYSTADROPS (CYSTEAMINE HYDROCHLORIDE) SOLUTION [RECORDATI RARE DISEASES, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241004_5d2bcce3-9b89-4141-aeb7-db00449047f5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55292-410-05 | 55292041005 | 1 BOTTLE, GLASS in 1 BOX (55292-410-05) / 5 mL in 1 BOTTLE, GLASS | 2020-08-19 | 0000-00-00 | No | No | Current |