FDA.reportPublic FDA data

Rolvedon

Product NDC
76961-101
11-digit product format
769610101
Labeler code
76961
Product ID
76961-101_9209fc63-aee3-43dc-9bc6-16c5ed73d858
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eflapegrastim-xnst
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Spectrum Pharmaceuticals, Inc.
Application
BLA761148
Marketing category
BLA
Marketing start
2022-10-18
Marketing end
2027-08-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rolvedon

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
6e436115-62e7-4729-aeb0-ff78ea685206Available 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
76961-101-01Rolvedon0.6 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76961-101-01ML - Milliliter76961-1012a3e623c-ab34-4785-8123-4b8b1097100b12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76961-101ROLVEDON (EFLAPEGRASTIM-XNST) INJECTION, SOLUTION [SPECTRUM PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20240316_6e436115-62e7-4729-aeb0-ff78ea685206.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 · 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
ndc (product): 76961-101
RolvedonEFLAPEGRASTIM-XNSTAssertio Specialty Pharmaceuticals, LLC2dc62c46-bb10-4a62-a459-d3eeeb6dd82f2026-02-11Warnings, Adverse reactionsExact identifier
application number: BLA761148

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 SyringePSN6e436115-62e7-4729-aeb0-ff78ea6852066
2612547ROLVEDON 13.2 MG in 0.6 ML Prefilled SyringePSN6e436115-62e7-4729-aeb0-ff78ea6852066
26125470.6 ML eflapegrastim-xnst 22 MG/ML Prefilled Syringe [Rolvedon]SBD6e436115-62e7-4729-aeb0-ff78ea6852066
26125410.6 ML eflapegrastim-xnst 22 MG/ML Prefilled SyringeSCD6e436115-62e7-4729-aeb0-ff78ea6852066
26125470.6 ML Rolvedon 22 MG/ML Prefilled SyringeSY6e436115-62e7-4729-aeb0-ff78ea6852066
2612541eflapegrastim-xnst 13.2 MG per 0.6 ML Prefilled SyringeSY6e436115-62e7-4729-aeb0-ff78ea6852066
2612547Rolvedon 13.2 MG per 0.6 ML Prefilled SyringeSY6e436115-62e7-4729-aeb0-ff78ea6852066

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76961-101-0176961010101.6 mL in 1 SYRINGE, GLASS (76961-101-01) 2022-10-182027-08-31NoNoCurrent