mysoline

Generic: primidone

Labeler: bausch health us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mysoline
Generic Name primidone
Labeler bausch health us, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 250 mg/1

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 66490-691
Product ID 66490-691_9d9f03b1-4eb4-4ba5-a357-600e368802c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA009170
Listing Expiration 2026-12-31
Marketing Start 2009-06-24

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66490691
Hyphenated Format 66490-691

Supplemental Identifiers

RxCUI
96304 198150 201747 207478
UNII
13AFD7670Q
NUI
N0000175753 N0000008486

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 mysoline (source: ndc)
Generic Name primidone (source: ndc)
Application Number NDA009170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (66490-691-10)
source: ndc

Packages (1)

66490-691-10 100 TABLET in 1 BOTTLE (66490-691-10)

Ingredients (1)

primidone (250 mg/1)

Linked Drug Pages (1)

Mysoline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9d9f03b1-4eb4-4ba5-a357-600e368802c6", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150", "201747", "207478"], "spl_set_id": ["af593171-dabb-4ea3-b44c-89ed457b2c46"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (66490-691-10)", "package_ndc": "66490-691-10", "marketing_start_date": "20090624"}], "brand_name": "Mysoline", "product_id": "66490-691_9d9f03b1-4eb4-4ba5-a357-600e368802c6", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "66490-691", "generic_name": "Primidone", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mysoline", "active_ingredients": [{"name": "PRIMIDONE", "strength": "250 mg/1"}], "application_number": "NDA009170", "marketing_category": "NDA", "marketing_start_date": "20090624", "listing_expiration_date": "20261231"}