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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 2026-03-26 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761166 ndc (product): 73536-500
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2587064 Internal RxNorm lookup 2587070 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
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 2026-06-01
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