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NDC 00143-9393-10 REMIFENTANIL HYDROCHLORIDE 5 mg/5mL Details
REMIFENTANIL HYDROCHLORIDE 5 mg/5mL
REMIFENTANIL HYDROCHLORIDE is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is REMIFENTANIL HYDROCHLORIDE.
Product Information
| NDC | 00143-9393 |
|---|---|
| Product ID | 0143-9393_76680bf5-083a-43d3-93c6-998cfbe321bb |
| Associated GPIs | 65100087102150 |
| GCN Sequence Number | 028226 |
| GCN Sequence Number Description | remifentanil HCl VIAL 5 MG INTRAVEN |
| HIC3 | H3H |
| HIC3 Description | OPIOID ANALGESIC, ANESTHETIC ADJUNCT AGENTS |
| GCN | 07210 |
| HICL Sequence Number | 011931 |
| HICL Sequence Number Description | REMIFENTANIL HCL |
| Brand/Generic | Generic |
| Proprietary Name | REMIFENTANIL HYDROCHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | REMIFENTANIL HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/5mL |
| Substance Name | REMIFENTANIL HYDROCHLORIDE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA210594 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00143-9393-10 (00143939310)
| NDC Package Code | 0143-9393-10 |
|---|---|
| Billing NDC | 00143939310 |
| Package | 10 VIAL in 1 CARTON (0143-9393-10) / 10 mL in 1 VIAL (0143-9393-01) |
| Marketing Start Date | 2021-05-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |