miglitol

Generic: miglitol

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name miglitol
Generic Name miglitol
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

miglitol 100 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-305
Product ID 69367-305_d28d00da-e102-098c-e053-2995a90a8121
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 69367305
Hyphenated Format 69367-305

Supplemental Identifiers

RxCUI
205329 205330 205331
UPC
0369367303019 0369367304016 0369367305013
UNII
0V5436JAQW
NUI
N0000000166 N0000175559

Packaging Origin

Original Packager
true

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 (69367-305-01)
source: ndc

Packages (1)

69367-305-01 100 TABLET, COATED in 1 BOTTLE (69367-305-01)

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": "d28d00da-e102-098c-e053-2995a90a8121", "openfda": {"nui": ["N0000000166", "N0000175559"], "upc": ["0369367303019", "0369367304016", "0369367305013"], "unii": ["0V5436JAQW"], "rxcui": ["205329", "205330", "205331"], "spl_set_id": ["b8da2015-d254-2425-e053-2995a90acf0e"], "pharm_class_epc": ["alpha-Glucosidase Inhibitor [EPC]"], "pharm_class_moa": ["alpha Glucosidase Inhibitors [MoA]"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (69367-305-01)", "package_ndc": "69367-305-01", "marketing_start_date": "20210115"}], "brand_name": "Miglitol", "product_id": "69367-305_d28d00da-e102-098c-e053-2995a90a8121", "dosage_form": "TABLET, COATED", "pharm_class": ["alpha Glucosidase Inhibitors [MoA]", "alpha-Glucosidase Inhibitor [EPC]"], "product_ndc": "69367-305", "generic_name": "Miglitol", "labeler_name": "Westminster Pharmaceuticals, LLC", "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"}