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NDC 71390-0011-11 BYFAVO 2.5 mg/mL Details
BYFAVO 2.5 mg/mL
BYFAVO is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Acacia Pharma, Ltd.. The primary component is REMIMAZOLAM BESYLATE.
Product Information
| NDC | 71390-0011 |
|---|---|
| Product ID | 71390-011_e612bcf4-fce1-4b8b-aa7a-a58ad0dce6b2 |
| Associated GPIs | 60201029102120 |
| GCN Sequence Number | 081257 |
| GCN Sequence Number Description | remimazolam besylate VIAL 20 MG INTRAVEN |
| HIC3 | H22 |
| HIC3 Description | GENERAL ANESTHETICS,INJECTABLE-BENZODIAZEPINE TYPE |
| GCN | 48313 |
| HICL Sequence Number | 046678 |
| HICL Sequence Number Description | REMIMAZOLAM BESYLATE |
| Brand/Generic | Brand |
| Proprietary Name | BYFAVO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | remimazolam besylate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 2.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | REMIMAZOLAM BESYLATE |
| Labeler Name | Acacia Pharma, Ltd. |
| Pharmaceutical Class | n/a |
| DEA Schedule | CIV |
| Marketing Category | NDA |
| Application Number | NDA212295 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71390-0011-11 (71390001111)
| NDC Package Code | 71390-011-11 |
|---|---|
| Billing NDC | 71390001111 |
| Package | 10 VIAL in 1 CARTON (71390-011-11) / 8 mL in 1 VIAL (71390-011-00) |
| Marketing Start Date | 2020-10-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |