Ramelteon Tablets

SPL v6

SPL

SPL Set ID 14ba7994-476a-4978-8cac-29989335a63c

Route

ORAL

Published

Effective Date 2024-07-30

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ramelteon (8 mg)

Inactive Ingredients

Anhydrous Lactose Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Hypromellose 2910 (3 Mpa.s) Polyethylene Glycol 6000 Povidone Silicon Dioxide Sodium Stearyl Fumarate Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 1344 Shape: round Color: yellow Size: 7 mm Score: 1

Marketing Status

ANDA Active Since 2019-07-23

Description

NDC 70771-1495-3 Ramelteon Tablets, 8 mg 30 Tablets Rx only

Medication Information

Description

NDC 70771-1495-3 Ramelteon Tablets, 8 mg 30 Tablets Rx only

Package Label.principal Display Panel

NDC 70771-1495-3

Ramelteon Tablets, 8 mg

30 Tablets

Rx only

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1495-3

Ramelteon Tablets, 8 mg

30 Tablets

Rx only

Advanced Ingredient Data

[{"name": "RAMELTEON", "unii": "901AS54I69", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (3 MPA.S)", "unii": "0VUT3PMY82", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 6000", "unii": "30IQX730WE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STEARYL FUMARATE", "unii": "7CV7WJK4UI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1495-3 Ramelteon Tablets, 8 mg 30 Tablets Rx only"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:44:02.127371 · Updated: 2026-03-14T22:18:33.371936