Home NDC 71390-011 BYFAVO
Product NDC 71390-011
11-digit product format 713900011
Labeler code 71390
Product ID 71390-011_4da618a9-2e04-4d75-922b-173d22b4e84c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name remimazolam besylate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Acacia Pharma, Ltd.
Application NDA212295
Marketing category NDA
Marketing start 2020-10-06
Substance REMIMAZOLAM BESYLATE
Active strength 2.5 mg/mL
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212295-001 BYFAVO REMIMAZOLAM BESYLATE EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06
Orange Book patents# Current patent rows page 1 of 1 · 11 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212295-001 10472365 2027-07-10 U-2968 2020-10-23 N212295-001 10961250 2027-07-10 U-2968 Drug product 2022-07-08 N212295-001 9777007 2027-07-10 Drug product 2020-10-23 N212295-001 9914738 2027-07-10 Drug product 2020-10-23 N212295-001 10052334 2031-11-07 U-2968 2020-10-23 N212295-001 10195210 2031-11-07 U-2968 2020-10-23 N212295-001 10342800 2031-11-07 U-2968 2020-10-23 N212295-001 10722522 2031-11-07 U-2968 2020-10-23 N212295-001 9737547 2031-11-07 U-2968 2020-10-23 N212295-001 9561236 2033-04-30 U-2968 2020-10-23 N212295-001 9827251 2034-01-13 U-2968 2020-10-23
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-07-02 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 11 · 408 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N212295-001 10472365 2027-07-10 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 10961250 2027-07-10 U-2968 Drug product 2022-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 9777007 2027-07-10 Drug product 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 9914738 2027-07-10 Drug product 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 10052334 2031-11-07 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 10195210 2031-11-07 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 10342800 2031-11-07 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 10722522 2031-11-07 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 9737547 2031-11-07 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 9561236 2033-04-30 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 9827251 2034-01-13 U-2968 2020-10-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212295-001 10472365 2027-07-10 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 10961250 2027-07-10 U-2968 Drug product 2022-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 9777007 2027-07-10 Drug product 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 9914738 2027-07-10 Drug product 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 10052334 2031-11-07 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 10195210 2031-11-07 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 10342800 2031-11-07 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 10722522 2031-11-07 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 9737547 2031-11-07 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 9561236 2033-04-30 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 9827251 2034-01-13 U-2968 2020-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 10472365 2027-07-10 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 10961250 2027-07-10 U-2968 Drug product 2022-07-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 9777007 2027-07-10 Drug product 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 9914738 2027-07-10 Drug product 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 10052334 2031-11-07 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 10195210 2031-11-07 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 10342800 2031-11-07 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 10722522 2031-11-07 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 9737547 2031-11-07 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 9561236 2033-04-30 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 9827251 2034-01-13 U-2968 2020-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212295-001 10472365 2027-07-10 U-2968 2020-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212295-001 10961250 2027-07-10 U-2968 Drug product 2022-07-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212295-001 9777007 2027-07-10 Drug product 2020-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212295-001 9914738 2027-07-10 Drug product 2020-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212295-001 10052334 2031-11-07 U-2968 2020-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212295-001 10195210 2031-11-07 U-2968 2020-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212295-001 10342800 2031-11-07 U-2968 2020-10-23 6a471c1ec25d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base BYFAVO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength REMIMAZOLAM BESYLATE 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 280XQ6482H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2383946 Internal RxNorm lookup 2383951 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71390-011-00 BYFAVO 8 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 8 9 71390-011-11 BYFAVO 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71390-011 BYFAVO (REMIMAZOLAM BESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACACIA PHARMA, LTD.] 9 Current NDC, Legacy NDC, 2 package rows 20250228_4e1838f2-b999-41a7-a761-d94f09aa531f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BYFAVO REMIMAZOLAM BESYLATE Acacia Pharma, Ltd. 4e1838f2-b999-41a7-a761-d94f09aa531f 2025-02-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 212295 application number: NDA212295 ndc (product): 71390-011
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71390-011-00 71390001100 8 mL in 1 VIAL 8 ml Historical 71390-011-11 71390001111 10 VIAL in 1 CARTON (71390-011-11) / 8 mL in 1 VIAL (71390-011-00) 10 vial 2020-10-06 0000-00-00 No No Current