ELCYS
- Product NDC
- 51754-1008
- 11-digit product format
- 517541008
- Labeler code
- 51754
- Product ID
- 51754-1008_5e7be8d4-66c2-4bab-849f-46eaac9996cb
- 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
- 2023-12-12
- Substance
- CYSTEINE HYDROCHLORIDE
- Active strength
- 50 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ELCYS
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYSTEINE HYDROCHLORIDE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZT934N0X4W |
| Rxcui | 1486165, 2671585 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51754-1008-1 | ELCYS | 50 mL in 1 VIAL | INJECTION, SOLUTION | 50 | | 3 |
| 51754-1008-1 | ELCYS | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
| 51754-1008-4 | ELCYS | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 2 |
| 51754-1008-4 | ELCYS | 50 mL in 1 VIAL | INJECTION, SOLUTION | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51754-1008 | ELCYS (CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC] | 2 | Current NDC, 2 package rows | 20240202_9a52ae2f-1cea-4ad5-a074-66bbf06578d3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51754-1008-1 | 51754100801 | 1 VIAL in 1 CARTON (51754-1008-1) / 50 mL in 1 VIAL | 1 vial | 2024-01-01 | No | No | Historical |
| 51754-1008-4 | 51754100804 | 25 VIAL in 1 CARTON (51754-1008-4) / 50 mL in 1 VIAL | 25 vial | 2024-01-01 | No | No | Historical |