FDA.reportPublic FDA data

Nateglinide

Product NDC
60687-684
11-digit product format
606870684
Labeler code
60687
Product ID
60687-684_2b2511ab-0768-113f-e063-6394a90a809d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nateglinide
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077463
Marketing category
ANDA
Marketing start
2023-01-03
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
60687-684-11Nateglinide1 in 1 BLISTER PACKTABLET15
60687-684-21Nateglinide30 in 1 CARTONTABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-684-11EA - Each60687-684960c75ff-528f-45fc-b92d-1c9113effdb312022-10-06
60687-684-21EA - Each60687-684388b2707-5840-454f-8b2a-5b45d28b90b912022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-684NATEGLINIDE TABLET [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20250109_b17ead66-dc11-4e54-9ba6-00619510f27b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311919nateglinide 120 MG Oral TabletPSNb17ead66-dc11-4e54-9ba6-00619510f27b5
314142nateglinide 60 MG Oral TabletPSNb17ead66-dc11-4e54-9ba6-00619510f27b5
311919nateglinide 120 MG Oral TabletSCDb17ead66-dc11-4e54-9ba6-00619510f27b5
314142nateglinide 60 MG Oral TabletSCDb17ead66-dc11-4e54-9ba6-00619510f27b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-684-11606870684111 in 1 BLISTER PACKHistorical
60687-684-216068706842130 BLISTER PACK in 1 CARTON (60687-684-21) / 1 TABLET in 1 BLISTER PACK (60687-684-11) 30 blister pack2023-01-030000-00-00NoNoCurrent