MedPath
FDA Product

Nateglinide

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Nateglinide

55111-328

Regulatory Information

55111-328

ANDA077461

C73584

January 28, 2019

USA

These highlights do not include all the information needed to use NATEGLINIDE TABLETS safely and effectively. See full prescribing information for NATEGLINIDE TABLETS. NATEGLINIDE tablets, for oral use Initial U.S. Approval: 2000

HUMAN PRESCRIPTION DRUG LABEL

10

Company Information

650562841

Active Ingredients

nateglinide

Quantity: 60 mg in 1 1

Code: 41X3PWK4O2

Class Code: ACTIB

Inactive Ingredients

silicon dioxide

Code: ETJ7Z6XBU4

Class Code: IACT

sodium lauryl sulfate

Code: 368GB5141J

Class Code: IACT

croscarmellose sodium

Code: M28OL1HH48

Class Code: IACT

mannitol

Code: 3OWL53L36A

Class Code: IACT

copovidone

Code: D9C330MD8B

Class Code: IACT

talc

Code: 7SEV7J4R1U

Class Code: IACT

sodium stearyl fumarate

Code: 7CV7WJK4UI

Class Code: IACT

carnauba wax

Code: R12CBM0EIZ

Class Code: IACT

starch, corn

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

nateglinide

Code: 41X3PWK4O2

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