Label: RAMELTEON tablet
- NDC Code(s): 70771-1495-1, 70771-1495-3, 70771-1495-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 27, 2023
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INGREDIENTS AND APPEARANCE
RAMELTEON
ramelteon tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1495 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RAMELTEON (UNII: 901AS54I69) (RAMELTEON - UNII:901AS54I69) RAMELTEON 8 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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 Marketing Start Date Marketing End Date 1 NDC:70771-1495-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2019 2 NDC:70771-1495-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2019 3 NDC:70771-1495-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211567 07/23/2019 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1495) , MANUFACTURE(70771-1495)
