United States· US:82497-132_ef8eef01-b278-484e-b4d4-85905e756674

Rolvedon

A eflapegrastim product containing eflapegrastim, registered in United States by Assertio Specialty Pharmaceuticals, LLC.

ATC L03AA19US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedRolvedonATCL03AA19REGISTER NO.US:82497-132_ef8eef01…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
EFLAPEGRASTIM
Manufacturer
Assertio Specialty Pharmaceuticals, LLC
Country
United States (US)
ATC code
L03AA19
ATC class
Eflapegrastim
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    82497-132-01
  • ndc11
    8249713201
    .6 mL in 1 SYRINGE, GLASS (82497-132-01)

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same class

Other records under L03AA19

Eflapegrastim, as other registers publish it.

All eflapegrastim products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/5d5e2db9-7b2f-46c0-a0ee-2a46858f371e
GET /v1/drugs/5d5e2db9-7b2f-46c0-a0ee-2a46858f371e?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "SUBCUTANEOUS",
  "source": "ndc",
  "strength": "13.2",
  "substance": "EFLAPEGRASTIM",
  "productndc": "82497-132",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/.6mL",
  "application_number": "BLA761148",
  "marketing_category": "BLA"
}

See everything about eflapegrastim.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.