Repaglinide

Product NDC
33342-248
11-digit product format
333420248
Labeler code
33342
Product ID
33342-248_7a93246c-9323-40c4-b590-a40dcb133c8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Repaglinide
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
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
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
33342-248-11Repaglinide100 in 1 BOTTLETABLET1001
33342-248-44Repaglinide1000 in 1 BOTTLETABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-248REPAGLINIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20230405_7a93246c-9323-40c4-b590-a40dcb133c8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200257repaglinide 0.5 MG Oral TabletPSN7a93246c-9323-40c4-b590-a40dcb133c8c1
200257repaglinide 0.5 MG Oral TabletPSN9f2006d9-e0c0-4cc4-b2c9-84b7d9f771731
200256repaglinide 1 MG Oral TabletPSN7a93246c-9323-40c4-b590-a40dcb133c8c1
200258repaglinide 2 MG Oral TabletPSN7a93246c-9323-40c4-b590-a40dcb133c8c1
200257repaglinide 0.5 MG Oral TabletSCD7a93246c-9323-40c4-b590-a40dcb133c8c1
200257repaglinide 0.5 MG Oral TabletSCD9f2006d9-e0c0-4cc4-b2c9-84b7d9f771731
200256repaglinide 1 MG Oral TabletSCD7a93246c-9323-40c4-b590-a40dcb133c8c1
200258repaglinide 2 MG Oral TabletSCD7a93246c-9323-40c4-b590-a40dcb133c8c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-248-1133342024811100 TABLET in 1 BOTTLE (33342-248-11) 100 tablet2023-03-22NoNoCurrent
33342-248-44333420248441000 TABLET in 1 BOTTLE (33342-248-44) 1000 tablet2023-03-22NoNoCurrent