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NDC 63323-0808-11 Fentanyl Citrate 50 ug/mL Details
Fentanyl Citrate 50 ug/mL
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 | 63323-0808 |
|---|---|
| Product ID | 63323-808_2fd7132a-0a1d-4b7c-8f38-d163ce092fd0 |
| Associated GPIs | 6510002510E511 |
| GCN Sequence Number | 041386 |
| GCN Sequence Number Description | fentanyl citrate/PF SYRINGE 50 MCG/ML INJECTION |
| HIC3 | H3H |
| HIC3 Description | OPIOID ANALGESIC, ANESTHETIC ADJUNCT AGENTS |
| GCN | 32808 |
| 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 | 50 |
| Active Ingredient Units | ug/mL |
| 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 | 2024-12-31 |
Package
NDC 63323-0808-11 (63323080811)
| NDC Package Code | 63323-808-11 |
|---|---|
| Billing NDC | 63323080811 |
| Package | 10 SYRINGE in 1 CARTON (63323-808-11) / 1 mL in 1 SYRINGE (63323-808-01) |
| Marketing Start Date | 2020-09-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |