Repaglinide

Product NDC
62135-948
11-digit product format
621350948
Labeler code
62135
Product ID
62135-948_342983dc-ded9-2234-e063-6294a90ac97f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Repaglinide
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA078555
Marketing category
ANDA
Marketing start
2014-01-22
Substance
REPAGLINIDE
Active strength
2 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
REPAGLINIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii668Z8C33LU
Rxcui200256, 200257, 200258

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
62135-948-90Repaglinide90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-948-90EA - Each62135-9488da6ed50-de69-4dd9-940a-de3c68e6f5b912025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-948REPAGLINIDE TABLET [CHARTWELL RX, LLC]1Current NDC, 1 package rows20250504_cb995e92-295e-4638-a064-978211f5afe1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200257repaglinide 0.5 MG Oral TabletPSNcb995e92-295e-4638-a064-978211f5afe11
200256repaglinide 1 MG Oral TabletPSNcb995e92-295e-4638-a064-978211f5afe11
200258repaglinide 2 MG Oral TabletPSNcb995e92-295e-4638-a064-978211f5afe11
200257repaglinide 0.5 MG Oral TabletSCDcb995e92-295e-4638-a064-978211f5afe11
200256repaglinide 1 MG Oral TabletSCDcb995e92-295e-4638-a064-978211f5afe11
200258repaglinide 2 MG Oral TabletSCDcb995e92-295e-4638-a064-978211f5afe11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-948-906213509489090 TABLET in 1 BOTTLE (62135-948-90) 90 tablet2025-04-24NoNoCurrent