FDA.reportPublic FDA data

Miglitol

Product NDC
71205-935
11-digit product format
712050935
Labeler code
71205
Product ID
71205-935_c8003a86-3d92-4acb-b8b8-fe52835c83f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Miglitol
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203965
Marketing category
ANDA
Marketing start
2021-01-15
Substance
MIGLITOL
Active strength
25 mg/1
Pharmacologic classes
alpha Glucosidase Inhibitors [MoA], alpha-Glucosidase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Miglitol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIGLITOL25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0V5436JAQW
Rxcui205329, 205330, 205331

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-935-00Miglitol100 in 1 BOTTLETABLET, COATED1002
71205-935-30Miglitol30 in 1 BOTTLETABLET, COATED302
71205-935-60Miglitol60 in 1 BOTTLETABLET, COATED602
71205-935-90Miglitol90 in 1 BOTTLETABLET, COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-935-00EA - Each71205-93531b09414-ecae-4eb3-803d-8517a9acb28512021-04-08
71205-935-30EA - Each71205-935389a9766-ae60-4c29-a92d-185073416c2e12021-04-08
71205-935-60EA - Each71205-93565eb5bf3-607e-4f5e-b735-2748ad6d414a12021-04-08
71205-935-90EA - Each71205-9351375dc7c-b816-4fdf-b0dd-54d5aa306bdb12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-935MIGLITOL TABLET, COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 4 package rows20220426_f16ecb50-e54e-43e1-8789-eaf5bc94f332.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205331miglitol 100 MG Oral TabletPSNf16ecb50-e54e-43e1-8789-eaf5bc94f3322
205329miglitol 25 MG Oral TabletPSNf16ecb50-e54e-43e1-8789-eaf5bc94f3322
205330miglitol 50 MG Oral TabletPSNf16ecb50-e54e-43e1-8789-eaf5bc94f3322
205331miglitol 100 MG Oral TabletSCDf16ecb50-e54e-43e1-8789-eaf5bc94f3322
205329miglitol 25 MG Oral TabletSCDf16ecb50-e54e-43e1-8789-eaf5bc94f3322
205330miglitol 50 MG Oral TabletSCDf16ecb50-e54e-43e1-8789-eaf5bc94f3322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-935-0071205093500100 TABLET, COATED in 1 BOTTLE (71205-935-00) 2021-03-010000-00-00NoNoCurrent
71205-935-307120509353030 TABLET, COATED in 1 BOTTLE (71205-935-30) 2021-03-010000-00-00NoNoCurrent
71205-935-607120509356060 TABLET, COATED in 1 BOTTLE (71205-935-60) 2021-03-010000-00-00NoNoCurrent
71205-935-907120509359090 TABLET, COATED in 1 BOTTLE (71205-935-90) 2021-03-010000-00-00NoNoCurrent