opfolda

Generic: miglustat

Labeler: amicus therapeutics us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name opfolda
Generic Name miglustat
Labeler amicus therapeutics us, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

miglustat 65 mg/1

Manufacturer
AMICUS THERAPEUTICS US, LLC

Identifiers & Regulatory

Product NDC 71904-300
Product ID 71904-300_82a91fa0-6c38-452c-a5d0-2c2f7355f540
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215211
Listing Expiration 2026-12-31
Marketing Start 2023-10-11

Pharmacologic Class

Established (EPC)
glucosylceramide synthase inhibitor [epc] enzyme stabilizer [epc]
Mechanism of Action
glucosylceramide synthase inhibitors [moa] enzyme stabilizers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71904300
Hyphenated Format 71904-300

Supplemental Identifiers

RxCUI
2667426 2667432
UPC
0371904300016 0371904300023 0371904300030
UNII
ADN3S497AZ
NUI
N0000175783 N0000020019 N0000194077 N0000194078

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 opfolda (source: ndc)
Generic Name miglustat (source: ndc)
Application Number NDA215211 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 65 mg/1
source: ndc
Packaging
  • 4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTIC
  • 24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTIC
  • 100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-03) / 1 CAPSULE in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

71904-300-01 4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTIC 71904-300-02 24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTIC 71904-300-03 100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-03) / 1 CAPSULE in 1 BOTTLE, PLASTIC

Ingredients (1)

miglustat (65 mg/1)

Linked Drug Pages (1)

OPFOLDA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "82a91fa0-6c38-452c-a5d0-2c2f7355f540", "openfda": {"nui": ["N0000175783", "N0000020019", "N0000194077", "N0000194078"], "upc": ["0371904300016", "0371904300023", "0371904300030"], "unii": ["ADN3S497AZ"], "rxcui": ["2667426", "2667432"], "spl_set_id": ["d7c38298-37db-5a80-e053-2995a90aee40"], "pharm_class_epc": ["Glucosylceramide Synthase Inhibitor [EPC]", "Enzyme Stabilizer [EPC]"], "pharm_class_moa": ["Glucosylceramide Synthase Inhibitors [MoA]", "Enzyme Stabilizers [MoA]"], "manufacturer_name": ["AMICUS THERAPEUTICS US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01)  / 1 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "71904-300-01", "marketing_start_date": "20231011"}, {"sample": false, "description": "24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02)  / 1 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "71904-300-02", "marketing_start_date": "20231011"}, {"sample": false, "description": "100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-03)  / 1 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "71904-300-03", "marketing_start_date": "20231011"}], "brand_name": "OPFOLDA", "product_id": "71904-300_82a91fa0-6c38-452c-a5d0-2c2f7355f540", "dosage_form": "CAPSULE", "pharm_class": ["Enzyme Stabilizer [EPC]", "Enzyme Stabilizers [MoA]", "Glucosylceramide Synthase Inhibitor [EPC]", "Glucosylceramide Synthase Inhibitors [MoA]"], "product_ndc": "71904-300", "generic_name": "miglustat", "labeler_name": "AMICUS THERAPEUTICS US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OPFOLDA", "active_ingredients": [{"name": "MIGLUSTAT", "strength": "65 mg/1"}], "application_number": "NDA215211", "marketing_category": "NDA", "marketing_start_date": "20231011", "listing_expiration_date": "20261231"}