Nateglinide

Product NDC
0591-3355
11-digit product format
005913355
Labeler code
0591
Product ID
0591-3355_ead87332-2796-4cae-b377-5e54aae8a3ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nateglinide
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA077462
Marketing category
ANDA
Marketing start
2011-05-18
Marketing end
0000-00-00
Substance
NATEGLINIDE
Active strength
120 mg/1
Pharmacologic classes
Glinide [EPC],Potassium Channel Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3355-01EA - Each0591-335565a28d1d-8ad7-42c0-b07b-c160a21d9f2b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NATEGLINIDEACTIVE INGREDIENT41X3PWK4O2NATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
NATEGLINIDEACTIVE MOIETY41X3PWK4O2NATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357NATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
FUMARIC ACIDINACTIVE INGREDIENT88XHZ13131NATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82NATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6NATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNATEGLINIDE TABLET [WATSON LABORATORIES, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3355NATEGLINIDE TABLET [ACTAVIS PHARMA, INC.]11Legacy NDC20230805_a7e9f62e-32f8-4a89-8588-74d029c8f6a2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3355-0100591335501100 TABLET in 1 BOTTLE, PLASTIC (0591-3355-01) 100 tablet2011-05-180000-00-00NoNoCurrent