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NDC 51754-1008-03 ELCYS 50 mg/mL Details
ELCYS 50 mg/mL
ELCYS is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Exela Pharma Sciences, LLC. The primary component is CYSTEINE HYDROCHLORIDE.
Product Information
NDC | 51754-1008 |
---|---|
Product ID | 51754-1008_9a52ae2f-1cea-4ad5-a074-66bbf06578d3 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | ELCYS |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Cysteine Hydrochloride |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 50 |
Active Ingredient Units | mg/mL |
Substance Name | CYSTEINE HYDROCHLORIDE |
Labeler Name | Exela Pharma Sciences, LLC |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA210660 |
Listing Certified Through | 2024-12-31 |
Package
NDC 51754-1008-03 (51754100803)
NDC Package Code | 51754-1008-3 |
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Billing NDC | 51754100803 |
Package | 10 CARTON in 1 CASE (51754-1008-3) / 1 VIAL in 1 CARTON (51754-1008-1) / 50 mL in 1 VIAL |
Marketing Start Date | 2023-12-12 |
NDC Exclude Flag | N |
Pricing Information | N/A |