Ramelteon

Basic Information

Product Name

Ramelteon

FDA Product Code

42291-776

Regulatory Information

NDC Product Code

42291-776

Application Number

ANDA213186

Marketing Category

C73584

Effective Date

January 10, 2024

Territorial Authority

USA

FDA Title

RAMELTEON Tablets Rx Only These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS . Initial U.S. Approval: 2005

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

RAMELTEON

Quantity: 8 mg in 1 1

Code: 901AS54I69

Class Code: ACTIB

Inactive Ingredients

COPOVIDONE

Code: D9C330MD8B

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

HYDROXYPROPYL CELLULOSE

Code: RFW2ET671P

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

Code: 901AS54I69

Ramelteon

Basic Information

Regulatory Information

Company Information

Active Ingredients

Inactive Ingredients

COPOVIDONE

FERRIC OXIDE YELLOW

LACTOSE MONOHYDRATE

HYDROXYPROPYL CELLULOSE

MAGNESIUM STEARATE

POLYETHYLENE GLYCOL, UNSPECIFIED

STARCH, CORN

TITANIUM DIOXIDE

Active Moieties

RAMELTEON