primidone

Generic: primidone

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

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler oxford pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 50 mg/1

Manufacturer
Oxford Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69584-684
Product ID 69584-684_86b0848d-c247-4e50-bc01-dce7dc157605
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040586
Listing Expiration 2026-12-31
Marketing Start 2021-02-22

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 69584684
Hyphenated Format 69584-684

Supplemental Identifiers

RxCUI
96304 198150
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 primidone (source: ndc)
Generic Name primidone (source: ndc)
Application Number ANDA040586 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (69584-684-10)
  • 500 TABLET in 1 BOTTLE, PLASTIC (69584-684-50)
source: ndc

Packages (2)

69584-684-10 100 TABLET in 1 BOTTLE, PLASTIC (69584-684-10) 69584-684-50 500 TABLET in 1 BOTTLE, PLASTIC (69584-684-50)

Ingredients (1)

primidone (50 mg/1)

Linked Drug Pages (1)

Primidone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "86b0848d-c247-4e50-bc01-dce7dc157605", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150"], "spl_set_id": ["439096a4-c5d5-4ad8-be9c-238973a3e290"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Oxford Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (69584-684-10)", "package_ndc": "69584-684-10", "marketing_start_date": "20210222"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (69584-684-50)", "package_ndc": "69584-684-50", "marketing_start_date": "20210222"}], "brand_name": "Primidone", "product_id": "69584-684_86b0848d-c247-4e50-bc01-dce7dc157605", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69584-684", "generic_name": "Primidone", "labeler_name": "Oxford Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Primidone", "active_ingredients": [{"name": "PRIMIDONE", "strength": "50 mg/1"}], "application_number": "ANDA040586", "marketing_category": "ANDA", "marketing_start_date": "20210222", "listing_expiration_date": "20261231"}