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NDC 63323-0806-05 Fentanyl Citrate 0.05 mg/mL Details
Fentanyl Citrate 0.05 mg/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 | 63323-0806 |
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Product ID | 63323-806_a3532e70-055b-479d-9b5a-bc56b7eb3101 |
Associated GPIs | 65100025102007 65100025102012 65100025102022 65100025102037 65100025102042 |
GCN Sequence Number | 041385 |
GCN Sequence Number Description | fentanyl citrate/PF VIAL 50 MCG/ML INJECTION |
HIC3 | H3H |
HIC3 Description | OPIOID ANALGESIC, ANESTHETIC ADJUNCT AGENTS |
GCN | 32807 |
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 | 0.05 |
Active Ingredient Units | mg/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 | ANDA210762 |
Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0806-05 (63323080605)
NDC Package Code | 63323-806-05 |
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Billing NDC | 63323080605 |
Package | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-806-13) |
Marketing Start Date | 2019-05-03 |
NDC Exclude Flag | N |
Pricing Information | N/A |