FDA.reportPublic FDA data

BESREMi Pen

Product NDC
73536-511
11-digit product format
735360511
Labeler code
73536
Product ID
73536-511_801f0478-b00c-4e98-90c0-0a32201be6a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPEGINTERFERON ALFA-2B
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
PharmaEssentia USA
Application
BLA761166
Marketing category
BLA
Marketing start
2026-06-25
Substance
ROPEGINTERFERON ALFA-2B
Active strength
500 ug/.5mL
Pharmacologic classes
Interferon alfa-2b [CS]; Interferon alfa-2b [EPC]
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 Pen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPEGINTERFERON ALFA-2B500 ug/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
981TME683SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2587064Internal RxNorm lookup
2587070Internal RxNorm lookup
2748665Internal RxNorm lookup
2748670Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9583405d-53a0-49dc-88eb-5e6384ebabcbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
3265cfce-68af-4a73-8541-5cd6e0b0b7f2Product name120220609
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BESREMiROPEGINTERFERON ALFA-2BPharmaEssentia USA9583405d-53a0-49dc-88eb-5e6384ebabcb2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761166
ndc (product): 73536-511

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761166Besremiropeginterferon alfa-2b-njft351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2587070BESREMi 500 MCG in 1 ML Prefilled SyringePSN9583405d-53a0-49dc-88eb-5e6384ebabcb11
2587064ropeginterferon alfa-2b-njft 500 MCG in 1 ML Prefilled SyringePSN9583405d-53a0-49dc-88eb-5e6384ebabcb11
25870701 ML ropeginterferon alfa-2b-njft 0.5 MG/ML Prefilled Syringe [Besremi]SBD9583405d-53a0-49dc-88eb-5e6384ebabcb11
25870641 ML ropeginterferon alfa-2b-njft 0.5 MG/ML Prefilled SyringeSCD9583405d-53a0-49dc-88eb-5e6384ebabcb11
2587070Besremi 500 MCG per 1 ML Prefilled SyringeSY9583405d-53a0-49dc-88eb-5e6384ebabcb11
2587064ropeginterferon alfa-2b-njft 500 MCG per 1 ML Prefilled SyringeSY9583405d-53a0-49dc-88eb-5e6384ebabcb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
73536-511-01735360511011 CARTRIDGE in 1 CARTON (73536-511-01) / .5 mL in 1 CARTRIDGE1 cartridge2026-06-250Current