Nateglinide

Product NDC
71209-031
11-digit product format
712090031
Labeler code
71209
Product ID
71209-031_efa28dcf-77d5-4fb2-b6c0-4939a9bf4766
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nateglinide
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA206432
Marketing category
ANDA
Marketing start
2014-02-10
Substance
NATEGLINIDE
Active strength
120 mg/1
Pharmacologic classes
Glinide [EPC], Potassium Channel Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nateglinide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NATEGLINIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii41X3PWK4O2
Rxcui311919, 314142

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1a9c08ff-3275-8942-ea88-fa08fe78716cProduct name520190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71209-031-04Nateglinide90 in 1 BOTTLETABLET, COATED909
71209-031-05Nateglinide100 in 1 BOTTLETABLET, COATED1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-031NATEGLINIDE TABLET, COATED [CADILA PHARMACEUTICALS LIMITED]9Current NDC, Legacy NDC, 2 package rows20221229_c678b772-acba-4b59-a0b2-d70d84283425.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311919nateglinide 120 MG Oral TabletPSNc678b772-acba-4b59-a0b2-d70d842834259
314142nateglinide 60 MG Oral TabletPSNc678b772-acba-4b59-a0b2-d70d842834259
311919nateglinide 120 MG Oral TabletSCDc678b772-acba-4b59-a0b2-d70d842834259
314142nateglinide 60 MG Oral TabletSCDc678b772-acba-4b59-a0b2-d70d842834259

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71209-031-047120900310490 TABLET, COATED in 1 BOTTLE (71209-031-04) 2020-12-170000-00-00NoNoCurrent
71209-031-0571209003105100 TABLET, COATED in 1 BOTTLE (71209-031-05) 2014-02-100000-00-00NoNoCurrent