Prescription drug · NDA
Elcys (cysteine hydrochloride) NDC 51754-1008
Cysteine hydrochloride 50 mg/mL · Injection, Solution · Intravenous · Exela Pharma Sciences, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51754-1008-1 | 51754100801 | 1 VIAL in 1 CARTON (51754-1008-1) / 50 mL in 1 VIALMarketed from Jan 1, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Elcys
- Generic name (nonproprietary)
- cysteine hydrochloride
- Active ingredients
- Cysteine hydrochloride — 50 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Exela Pharma Sciences, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210660
- Marketing start
- Listing expires
- Identifiers
- Product ID 51754-1008_5e7be8d4-66c2-4bab-849f-46eaac9996cbSPL ID 5e7be8d4-66c2-4bab-849f-46eaac9996cbSPL set ID 52317b38-b2e6-4a1c-b5b0-43cada0d205eRxCUI 1486165, 2671585UNII ZT934N0X4W
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N451754100801followed by a unit qualifier and the quantityPackage 51754-1008-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ELCYS ® is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. ELCYS ® is a sulfur-containing amino acid indicated to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN. It can also be added…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 210660
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Elcyscysteine hydrochloride | Cysteine hydrochloride 10 mg/mL | Injection, SolutionIntravenous | Exela Pharma Sciences, LLC | 51754-1007 |
- openFDA data updated
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