LETROZOLE

Basic Information

Product Name

LETROZOLE

FDA Product Code

50268-476

Regulatory Information

NDC Product Code

50268-476

Application Number

ANDA200161

Marketing Category

C73584

Effective Date

January 9, 2024

Territorial Authority

USA

FDA Title

Letrozole Tablets, USP Rx only These highlights do not include all the information needed to use LETROZOLE TABLETS safely and effectively. See full prescribing information for LETROZOLE TABLETS. Initial U.S. Approval: 1997

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

LETROZOLE

Quantity: 2.5 mg in 1 1

Code: 7LKK855W8I

Class Code: ACTIB

Active Moieties

Code: 7LKK855W8I

LETROZOLE

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

HYPROMELLOSE 2910 (6 MPA.S)

POLYETHYLENE GLYCOL 8000

MICROCRYSTALLINE CELLULOSE

SILICON DIOXIDE

STARCH, CORN

TITANIUM DIOXIDE

TALC

SODIUM STARCH GLYCOLATE TYPE A POTATO

FERRIC OXIDE YELLOW

Active Moieties

LETROZOLE