Repaglinide

Product NDC
71335-2554
11-digit product format
713352554
Labeler code
71335
Product ID
71335-2554_0b66565e-c13c-4b45-82d4-72df4696fc70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Repaglinide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207209
Marketing category
ANDA
Marketing start
2023-03-22
Substance
REPAGLINIDE
Active strength
.5 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
Repaglinide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
REPAGLINIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii668Z8C33LU
Rxcui200257

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea03026f-270e-3aaa-c14e-f7103b55f75bProduct name320240321
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2554-1Repaglinide30 in 1 BOTTLETABLET301
71335-2554-2Repaglinide90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2554REPAGLINIDE TABLET [BRYANT RANCH PREPACK]1Current NDC, 2 package rows20250125_9f2006d9-e0c0-4cc4-b2c9-84b7d9f77173.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200257repaglinide 0.5 MG Oral TabletPSN9f2006d9-e0c0-4cc4-b2c9-84b7d9f771731
200257repaglinide 0.5 MG Oral TabletSCD9f2006d9-e0c0-4cc4-b2c9-84b7d9f771731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2554-17133525540130 TABLET in 1 BOTTLE (71335-2554-1) 30 tablet2025-01-23NoNoHistorical
71335-2554-27133525540290 TABLET in 1 BOTTLE (71335-2554-2) 90 tablet2025-01-23NoNoHistorical