FDA.reportPublic FDA data

Nateglinide

Product NDC
72241-003
11-digit product format
722410003
Labeler code
72241
Product ID
72241-003_af81465b-5f49-4eeb-8122-ef7fe5d90ddc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nateglinide
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA206432
Marketing category
ANDA
Marketing start
2021-08-19
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
72241-003-04Nateglinide90 in 1 BOTTLETABLET, COATED901
72241-003-05Nateglinide100 in 1 BOTTLETABLET, COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-003-04EA - Each72241-00340f9c74d-4067-44ed-86b0-c5e243f19acb12025-05-14
72241-003-05EA - Each72241-00387ee8704-67f8-44c4-b2f0-f18a612ad12412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-003NATEGLINIDE TABLET, COATED [MODAVAR PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 2 package rows20220312_af81465b-5f49-4eeb-8122-ef7fe5d90ddc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311919nateglinide 120 MG Oral TabletPSNaf81465b-5f49-4eeb-8122-ef7fe5d90ddc1
314142nateglinide 60 MG Oral TabletPSNaf81465b-5f49-4eeb-8122-ef7fe5d90ddc1
311919nateglinide 120 MG Oral TabletSCDaf81465b-5f49-4eeb-8122-ef7fe5d90ddc1
314142nateglinide 60 MG Oral TabletSCDaf81465b-5f49-4eeb-8122-ef7fe5d90ddc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72241-003-047224100030490 TABLET, COATED in 1 BOTTLE (72241-003-04) 2021-08-190000-00-00NoNoCurrent
72241-003-0572241000305100 TABLET, COATED in 1 BOTTLE (72241-003-05) 2021-08-190000-00-00NoNoCurrent