FDA.reportPublic FDA data

Rolvedon

Product NDC
82497-132
11-digit product format
824970132
Labeler code
82497
Product ID
82497-132_ef8eef01-b278-484e-b4d4-85905e756674
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eflapegrastim-xnst
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Assertio Specialty Pharmaceuticals, LLC
Application
BLA761148
Marketing category
BLA
Marketing start
2025-12-11
Substance
EFLAPEGRASTIM
Active strength
13.2 mg/.6mL
Pharmacologic classes
Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rolvedon
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EFLAPEGRASTIM13.2 mg/.6mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UT99UG9QJXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2612541Internal RxNorm lookup
2612547Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2dc62c46-bb10-4a62-a459-d3eeeb6dd82fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5c2a642c-6e4f-4716-bcdc-02b0032445b6Product name120231024

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82497-132-01Rolvedon0.6 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82497-132-01ML - Milliliter82497-1329fbafa59-7691-45d7-871c-5b7d48ef4ea812026-04-20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RolvedonEFLAPEGRASTIM-XNSTSpectrum Pharmaceuticals, Inc.6e436115-62e7-4729-aeb0-ff78ea6852062026-02-18Warnings, Adverse reactionsExact identifier
application number: BLA761148
RolvedonEFLAPEGRASTIM-XNSTAssertio Specialty Pharmaceuticals, LLC2dc62c46-bb10-4a62-a459-d3eeeb6dd82f2026-02-11Warnings, Adverse reactionsExact identifier
application number: BLA761148
ndc (product): 82497-132

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761148Rolvedoneflapegrastim-xnst351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2612541eflapegrastim-xnst 13.2 MG in 0.6 ML Prefilled SyringePSN2dc62c46-bb10-4a62-a459-d3eeeb6dd82f2
2612547ROLVEDON 13.2 MG in 0.6 ML Prefilled SyringePSN2dc62c46-bb10-4a62-a459-d3eeeb6dd82f2
26125470.6 ML eflapegrastim-xnst 22 MG/ML Prefilled Syringe [Rolvedon]SBD2dc62c46-bb10-4a62-a459-d3eeeb6dd82f2
26125410.6 ML eflapegrastim-xnst 22 MG/ML Prefilled SyringeSCD2dc62c46-bb10-4a62-a459-d3eeeb6dd82f2
26125470.6 ML Rolvedon 22 MG/ML Prefilled SyringeSY2dc62c46-bb10-4a62-a459-d3eeeb6dd82f2
2612541eflapegrastim-xnst 13.2 MG per 0.6 ML Prefilled SyringeSY2dc62c46-bb10-4a62-a459-d3eeeb6dd82f2
2612547Rolvedon 13.2 MG per 0.6 ML Prefilled SyringeSY2dc62c46-bb10-4a62-a459-d3eeeb6dd82f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82497-132-0182497013201.6 mL in 1 SYRINGE, GLASS (82497-132-01) 2025-12-11NoNoCurrent