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NDC 63323-0817-20 Fentanyl Citrate 100 ug/2mL Details
Fentanyl Citrate 100 ug/2mL
Fentanyl Citrate is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is FENTANYL CITRATE.
Product Information
| NDC | 63323-0817 |
|---|---|
| Product ID | 63323-817_8fca5c17-40f0-4b06-8beb-fd2f49229f7e |
| Associated GPIs | 6510002510E514 |
| GCN Sequence Number | 064814 |
| GCN Sequence Number Description | fentanyl citrate/PF SYRINGE 100MCG/2ML INTRAVEN |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 16763 |
| HICL Sequence Number | 025386 |
| HICL Sequence Number Description | FENTANYL CITRATE/PF |
| Brand/Generic | Generic |
| Proprietary Name | Fentanyl Citrate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fentanyl Citrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | ug/2mL |
| Substance Name | FENTANYL CITRATE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA212086 |
| Listing Certified Through | 2023-12-31 |
Package
NDC 63323-0817-20 (63323081720)
| NDC Package Code | 63323-817-20 |
|---|---|
| Billing NDC | 63323081720 |
| Package | 10 SYRINGE in 1 CARTON (63323-817-20) / 2 mL in 1 SYRINGE (63323-817-01) |
| Marketing Start Date | 2021-01-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |