ELCYS
- Product NDC
- 51754-1007
- 11-digit product format
- 517541007
- Labeler code
- 51754
- Product ID
- 51754-1007_04b033f6-7334-4aed-930f-beb3c349f193
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cysteine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Exela Pharma Sciences, LLC
- Application
- NDA210660
- Marketing category
- NDA
- Marketing start
- 2019-05-28
- Substance
- CYSTEINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ELCYS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYSTEINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZT934N0X4W |
| Rxcui | 1667993, 2169281 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51754-1007-1 | ELCYS | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 3 |
| 51754-1007-3 | ELCYS | 100 mL in 1 CARTON | INJECTION, SOLUTION | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51754-1007 | ELCYS (CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240202_e7652275-1c53-490c-82ad-e63867df5788.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 |
|---|
| 51754-1007-1 | 51754100701 | 10 mL in 1 VIAL (51754-1007-1) | 10 ml | 2019-05-28 | 0000-00-00 | No | No | Current |
| 51754-1007-3 | 51754100703 | 100 mL in 1 CARTON (51754-1007-3) | 100 ml | 2019-05-28 | 0000-00-00 | No | No | Current |