primidone

Generic: primidone

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

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 250 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-953
Product ID 82804-953_db761e34-8573-4f96-872c-e851b3004e5e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040586
Listing Expiration 2027-12-31
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 82804953
Hyphenated Format 82804-953

Supplemental Identifiers

RxCUI
96304 198150
UPC
0382804953301 0382804952304
UNII
13AFD7670Q
NUI
N0000175753 N0000008486

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
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (82804-953-00)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (82804-953-11)
  • 30 TABLET in 1 BOTTLE, PLASTIC (82804-953-30)
  • 500 TABLET in 1 BOTTLE, PLASTIC (82804-953-55)
  • 60 TABLET in 1 BOTTLE, PLASTIC (82804-953-60)
  • 120 TABLET in 1 BOTTLE, PLASTIC (82804-953-72)
  • 90 TABLET in 1 BOTTLE, PLASTIC (82804-953-90)
source: ndc

Packages (7)

82804-953-00 100 TABLET in 1 BOTTLE, PLASTIC (82804-953-00) 82804-953-11 1000 TABLET in 1 BOTTLE, PLASTIC (82804-953-11) 82804-953-30 30 TABLET in 1 BOTTLE, PLASTIC (82804-953-30) 82804-953-55 500 TABLET in 1 BOTTLE, PLASTIC (82804-953-55) 82804-953-60 60 TABLET in 1 BOTTLE, PLASTIC (82804-953-60) 82804-953-72 120 TABLET in 1 BOTTLE, PLASTIC (82804-953-72) 82804-953-90 90 TABLET in 1 BOTTLE, PLASTIC (82804-953-90)

Ingredients (1)

primidone (250 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": "db761e34-8573-4f96-872c-e851b3004e5e", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0382804953301", "0382804952304"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150"], "spl_set_id": ["db761e34-8573-4f96-872c-e851b3004e5e"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (82804-953-00)", "package_ndc": "82804-953-00", "marketing_start_date": "20260112"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (82804-953-11)", "package_ndc": "82804-953-11", "marketing_start_date": "20260112"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (82804-953-30)", "package_ndc": "82804-953-30", "marketing_start_date": "20260112"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (82804-953-55)", "package_ndc": "82804-953-55", "marketing_start_date": "20260112"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (82804-953-60)", "package_ndc": "82804-953-60", "marketing_start_date": "20260112"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (82804-953-72)", "package_ndc": "82804-953-72", "marketing_start_date": "20260112"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (82804-953-90)", "package_ndc": "82804-953-90", "marketing_start_date": "20260112"}], "brand_name": "Primidone", "product_id": "82804-953_db761e34-8573-4f96-872c-e851b3004e5e", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "82804-953", "generic_name": "Primidone", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Primidone", "active_ingredients": [{"name": "PRIMIDONE", "strength": "250 mg/1"}], "application_number": "ANDA040586", "marketing_category": "ANDA", "marketing_start_date": "20210222", "listing_expiration_date": "20271231"}