Repaglinide

Product NDC
65862-671
11-digit product format
658620671
Labeler code
65862
Product ID
65862-671_54d938ac-ebf2-49d0-8056-f65d8aadfb98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Repaglinide
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203820
Marketing category
ANDA
Marketing start
2014-01-22
Substance
REPAGLINIDE
Active strength
1 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
REPAGLINIDE1 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
65862-671-01Repaglinide100 in 1 BOTTLETABLET10011
65862-671-05Repaglinide500 in 1 BOTTLETABLET50011
65862-671-99Repaglinide1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-671-01EA - Each65862-67168c26d91-6db4-48a3-8daf-ad693bfa3ca312014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
REPAGLINIDEACTIVE INGREDIENT668Z8C33LUREPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]2
REPAGLINIDEACTIVE MOIETY668Z8C33LUREPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JREPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UREPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675REPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTREPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30REPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]2
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYREPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]2
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUREPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]2
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGREPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EREPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJREPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-671REPAGLINIDE TABLET [AUROBINDO PHARMA LIMITED]11Current NDC, Legacy NDC, 3 package rows20240516_68064989-47ea-4ed5-a20e-43c4ef6ec271.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200256repaglinide 1 MG Oral TabletPSN6ae28683-28cc-408e-90f9-6a3dddfc668d100
200256repaglinide 1 MG Oral TabletSCD6ae28683-28cc-408e-90f9-6a3dddfc668d100
200257repaglinide 0.5 MG Oral TabletPSN68064989-47ea-4ed5-a20e-43c4ef6ec27111
200256repaglinide 1 MG Oral TabletPSN68064989-47ea-4ed5-a20e-43c4ef6ec27111
200258repaglinide 2 MG Oral TabletPSN68064989-47ea-4ed5-a20e-43c4ef6ec27111
200257repaglinide 0.5 MG Oral TabletSCD68064989-47ea-4ed5-a20e-43c4ef6ec27111
200256repaglinide 1 MG Oral TabletSCD68064989-47ea-4ed5-a20e-43c4ef6ec27111
200258repaglinide 2 MG Oral TabletSCD68064989-47ea-4ed5-a20e-43c4ef6ec27111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-671-0165862067101100 TABLET in 1 BOTTLE (65862-671-01) 100 tablet2014-01-220000-00-00NoNoCurrent
65862-671-0565862067105500 TABLET in 1 BOTTLE (65862-671-05) 500 tablet2014-01-220000-00-00NoNoCurrent
65862-671-99658620671991000 TABLET in 1 BOTTLE (65862-671-99) 1000 tablet2014-01-220000-00-00NoNoCurrent