FDA.reportPublic FDA data

Repaglinide

Product NDC
57237-157
11-digit product format
572370157
Labeler code
57237
Product ID
57237-157_641cf1c4-6d24-4ad7-b85a-b2ddbb9263c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Repaglinide
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA203820
Marketing category
ANDA
Marketing start
2014-01-22
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
57237-157-01Repaglinide100 in 1 BOTTLETABLET1007
57237-157-05Repaglinide500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-157-01EA - Each57237-15786cd9e5b-af5e-44fe-b7d1-cfdcef83b6e512016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
REPAGLINIDEACTIVE INGREDIENT668Z8C33LUREPAGLINIDE TABLET [CITRON PHARMA LLC]1
REPAGLINIDEACTIVE MOIETY668Z8C33LUREPAGLINIDE TABLET [CITRON PHARMA LLC]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JREPAGLINIDE TABLET [CITRON PHARMA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UREPAGLINIDE TABLET [CITRON PHARMA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675REPAGLINIDE TABLET [CITRON PHARMA LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTREPAGLINIDE TABLET [CITRON PHARMA LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREPAGLINIDE TABLET [CITRON PHARMA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30REPAGLINIDE TABLET [CITRON PHARMA LLC]1
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYREPAGLINIDE TABLET [CITRON PHARMA LLC]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUREPAGLINIDE TABLET [CITRON PHARMA LLC]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGREPAGLINIDE TABLET [CITRON PHARMA LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EREPAGLINIDE TABLET [CITRON PHARMA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJREPAGLINIDE TABLET [CITRON PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-157REPAGLINIDE TABLET [RISING PHARMA HOLDINGS, INC.]7Current NDC, Legacy NDC, 2 package rows20240524_d7673e22-0dbb-4395-ad60-943d249203a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200257repaglinide 0.5 MG Oral TabletPSNd7673e22-0dbb-4395-ad60-943d249203a17
200256repaglinide 1 MG Oral TabletPSNd7673e22-0dbb-4395-ad60-943d249203a17
200258repaglinide 2 MG Oral TabletPSNd7673e22-0dbb-4395-ad60-943d249203a17
200257repaglinide 0.5 MG Oral TabletSCDd7673e22-0dbb-4395-ad60-943d249203a17
200256repaglinide 1 MG Oral TabletSCDd7673e22-0dbb-4395-ad60-943d249203a17
200258repaglinide 2 MG Oral TabletSCDd7673e22-0dbb-4395-ad60-943d249203a17
200257repaglinide 0.5 MG Oral TabletPSN3b150917-e2fd-4366-af83-ebc1d7297ca91
200257repaglinide 0.5 MG Oral TabletSCD3b150917-e2fd-4366-af83-ebc1d7297ca91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-157-0157237015701100 TABLET in 1 BOTTLE (57237-157-01) 100 tablet2014-01-220000-00-00NoNoCurrent
57237-157-0557237015705500 TABLET in 1 BOTTLE (57237-157-05) 500 tablet2014-01-220000-00-00NoNoCurrent