Ramelteon

RAMELTEON- ramelteon tablet
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1495-3

Ramelteon Tablets, 8 mg

30 Tablets

Rx only

Ramelteon Tablets
(click image for full-size original)
RAMELTEON
ramelteon tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1495
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:70771-1495-3 30 TABLET in 1 BOTTLE None
2 NDC:70771-1495-1 100 TABLET in 1 BOTTLE None
3 NDC:70771-1495-5 500 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 — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70771-1495), MANUFACTURE (70771-1495)

Revised: 09/2020 Cadila Healthcare Limited

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