Home NDC 73536-500 BESREMi
Product NDC 73536-500
11-digit product format 735360500
Labeler code 73536
Product ID 73536-500_4df852a2-10cb-235c-e063-6394a90a3f49
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ROPEGINTERFERON ALFA-2B
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler PharmaEssentia USA
Application BLA761166
Marketing category BLA
Marketing start 2021-11-12
Substance ROPEGINTERFERON ALFA-2B
Active strength 500 ug/mL
Pharmacologic classes Interferon alfa-2b [CS], Interferon alfa-2b [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base BESREMi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROPEGINTERFERON ALFA-2B 500 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 981TME683S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2587064 Internal RxNorm lookup 2587070 Internal RxNorm lookup 2748665 Internal RxNorm lookup 2748670 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 73536-500-01 BESREMi 1 mL in 1 SYRINGE, GLASS INJECTION 1 11 73536-500-01 BESREMi 1 in 1 CARTON INJECTION 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73536-500 BESREMI (ROPEGINTERFERON ALFA-2B) INJECTION [PHARMAESSENTIA USA] 8 Current NDC, Legacy NDC, 2 package rows 20241228_9583405d-53a0-49dc-88eb-5e6384ebabcb.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 BESREMi ROPEGINTERFERON ALFA-2B PharmaEssentia USA 9583405d-53a0-49dc-88eb-5e6384ebabcb 2026-08-25 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761166 ndc (product): 73536-500
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761166 Besremi ropeginterferon alfa-2b-njft 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 73536-500-01 73536050001 1 SYRINGE, GLASS in 1 CARTON (73536-500-01) / 1 mL in 1 SYRINGE, GLASS 2021-11-12 0000-00-00 No No Current