NATEGLINIDE

Product NDC
75834-206
11-digit product format
758340206
Labeler code
75834
Product ID
75834-206_4b5b12e1-59db-4ec2-a2be-9b60abc79ebf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NATEGLINIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA206432
Marketing category
ANDA
Marketing start
2019-09-25
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
1a9c08ff-3275-8942-ea88-fa08fe78716cProduct name520190711
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-206-01NATEGLINIDE100 in 1 BOTTLETABLET, COATED1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-206-01EA - Each75834-2067020311d-c0f8-4e5b-89fa-fd4d106a8d0f12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-206NATEGLINIDE TABLET, COATED [NIVAGEN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20210116_21b211b5-cc92-490f-9903-42fff6a946cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311919nateglinide 120 MG Oral TabletPSN21b211b5-cc92-490f-9903-42fff6a946cd2
314142nateglinide 60 MG Oral TabletPSN21b211b5-cc92-490f-9903-42fff6a946cd2
311919nateglinide 120 MG Oral TabletSCD21b211b5-cc92-490f-9903-42fff6a946cd2
314142nateglinide 60 MG Oral TabletSCD21b211b5-cc92-490f-9903-42fff6a946cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75834-206-0175834020601100 TABLET, COATED in 1 BOTTLE (75834-206-01) 2019-09-250000-00-00NoNoCurrent