United States · FDA National Drug Code directory

RAMELTEON

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
76420-880_2bea370a-97da-d286-e063-6294a90aca7f
Product NDC
76420-880
Form
TABLET, FILM COATED
Composition / generic term
RAMELTEON
Labeler
Asclemed USA, Inc.
Marketing category
ANDA
Marketing start / end (source format)
20230710
Source listing expiry
20261231

Source-listed ingredients

  • RAMELTEON — 8 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-880-01) · 76420-880-01
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-880-30) · 76420-880-30
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-880-60) · 76420-880-60
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-880-90) · 76420-880-90

Source and coverage

Open FDA National Drug Code directory

Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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