FDA.reportPublic FDA data

Miglitol

Product NDC
76333-127
11-digit product format
763330127
Labeler code
76333
Product ID
76333-127_9590040d-c6bd-dbf7-e053-2a95a90a834c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Miglitol
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Orient Pharma Co., Ltd.
Application
ANDA203965
Marketing category
ANDA
Marketing start
2015-07-31
Marketing end
0000-00-00
Substance
MIGLITOL
Active strength
100 mg/1
Pharmacologic classes
alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
da33ec65-27ed-1d6c-8c19-091ca4392bdaProduct name220150408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76333-127-112024-01-30C16284748780-11030e365-2a37-111a-e063-dadaa90a10e2Miglitol Tablets
76333-127-122024-01-30C16284748780-11030e365-2a37-111a-e063-dadaa90a10e2Miglitol Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76333-127-11Miglitol100 in 1 BOTTLETABLET, COATED1007
76333-127-12Miglitol1000 in 1 BOTTLETABLET, COATED10007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MiglitolACTIVE INGREDIENT0V5436JAQWMIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.]5
MiglitolACTIVE MOIETY0V5436JAQWMIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.]5
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.]5
HypromellosesINACTIVE INGREDIENT3NXW29V3WOMIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.]5
Magnesium StearateINACTIVE INGREDIENT70097M6I30MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.]5
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQMIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.]5
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HMIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.]5
Starch, CornINACTIVE INGREDIENTO8232NY3SJMIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.]5
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76333-127MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.]7Legacy NDC, 2 package rows20191024_192e6ed7-9e8c-4772-9e3b-5912a1c63a31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205331miglitol 100 MG Oral TabletPSN192e6ed7-9e8c-4772-9e3b-5912a1c63a317
205329miglitol 25 MG Oral TabletPSN192e6ed7-9e8c-4772-9e3b-5912a1c63a317
205330miglitol 50 MG Oral TabletPSN192e6ed7-9e8c-4772-9e3b-5912a1c63a317
205331miglitol 100 MG Oral TabletSCD192e6ed7-9e8c-4772-9e3b-5912a1c63a317
205329miglitol 25 MG Oral TabletSCD192e6ed7-9e8c-4772-9e3b-5912a1c63a317
205330miglitol 50 MG Oral TabletSCD192e6ed7-9e8c-4772-9e3b-5912a1c63a317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76333-127-1176333012711100 TABLET, COATED in 1 BOTTLE (76333-127-11) 2019-10-230000-00-00NoNoCurrent
76333-127-12763330127121000 TABLET, COATED in 1 BOTTLE (76333-127-12) 2019-10-230000-00-00NoNoCurrent