Ramelteon (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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RAMELTEON ramelteon tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76420-628(NDC:70710-1344)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAMELTEON (RAMELTEON) RAMELTEON 8 mg
Inactive Ingredients
Ingredient Name Strength
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
Product Characteristics
Color yellow (light yellow to beige coloured) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 1344
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76420-628-01 100 TABLET in 1 BOTTLE None
2 NDC:76420-628-30 30 TABLET in 1 BOTTLE None
3 NDC:76420-628-60 60 TABLET in 1 BOTTLE None
4 NDC:76420-628-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211567 07/23/2019
Labeler — Asclemed USA, Inc. (059888437)
Establishment
Name Address ID/FEI Operations
ASCLEMED USA INC. DBA ENOVACHEM 059888437 relabel (76420-628), repack (76420-628)

Revised: 11/2023 Asclemed USA, Inc.

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