miglitol

Generic: miglitol

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name miglitol
Generic Name miglitol
Labeler proficient rx lp
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

miglitol 100 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-937
Product ID 71205-937_c8003a86-3d92-4acb-b8b8-fe52835c83f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203965
Listing Expiration 2026-12-31
Marketing Start 2021-01-15

Pharmacologic Class

Established (EPC)
alpha-glucosidase inhibitor [epc]
Mechanism of Action
alpha glucosidase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205937
Hyphenated Format 71205-937

Supplemental Identifiers

RxCUI
205329 205330 205331
UPC
0371205935306
UNII
0V5436JAQW
NUI
N0000000166 N0000175559

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name miglitol (source: ndc)
Generic Name miglitol (source: ndc)
Application Number ANDA203965 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (71205-937-00)
  • 30 TABLET, COATED in 1 BOTTLE (71205-937-30)
  • 60 TABLET, COATED in 1 BOTTLE (71205-937-60)
  • 90 TABLET, COATED in 1 BOTTLE (71205-937-90)
source: ndc

Packages (4)

71205-937-00 100 TABLET, COATED in 1 BOTTLE (71205-937-00) 71205-937-30 30 TABLET, COATED in 1 BOTTLE (71205-937-30) 71205-937-60 60 TABLET, COATED in 1 BOTTLE (71205-937-60) 71205-937-90 90 TABLET, COATED in 1 BOTTLE (71205-937-90)

Ingredients (1)

miglitol (100 mg/1)

Linked Drug Pages (1)

Miglitol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c8003a86-3d92-4acb-b8b8-fe52835c83f5", "openfda": {"nui": ["N0000000166", "N0000175559"], "upc": ["0371205935306"], "unii": ["0V5436JAQW"], "rxcui": ["205329", "205330", "205331"], "spl_set_id": ["f16ecb50-e54e-43e1-8789-eaf5bc94f332"], "pharm_class_epc": ["alpha-Glucosidase Inhibitor [EPC]"], "pharm_class_moa": ["alpha Glucosidase Inhibitors [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (71205-937-00)", "package_ndc": "71205-937-00", "marketing_start_date": "20210301"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (71205-937-30)", "package_ndc": "71205-937-30", "marketing_start_date": "20210301"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (71205-937-60)", "package_ndc": "71205-937-60", "marketing_start_date": "20210301"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (71205-937-90)", "package_ndc": "71205-937-90", "marketing_start_date": "20210301"}], "brand_name": "Miglitol", "product_id": "71205-937_c8003a86-3d92-4acb-b8b8-fe52835c83f5", "dosage_form": "TABLET, COATED", "pharm_class": ["alpha Glucosidase Inhibitors [MoA]", "alpha-Glucosidase Inhibitor [EPC]"], "product_ndc": "71205-937", "generic_name": "Miglitol", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Miglitol", "active_ingredients": [{"name": "MIGLITOL", "strength": "100 mg/1"}], "application_number": "ANDA203965", "marketing_category": "ANDA", "marketing_start_date": "20210115", "listing_expiration_date": "20261231"}