primidone

Generic: primidone

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 250 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-545
Product ID 53746-545_ac6a300f-94ee-4b1c-9aaf-bce9b2c7781c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040866
Listing Expiration 2026-12-31
Marketing Start 2009-12-24

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 53746545
Hyphenated Format 53746-545

Supplemental Identifiers

RxCUI
96304 198150
UPC
0353746545015
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 ANDA040866 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-545-01)
  • 500 TABLET in 1 BOTTLE (53746-545-05)
  • 1000 TABLET in 1 BOTTLE (53746-545-10)
source: ndc

Packages (3)

53746-545-01 100 TABLET in 1 BOTTLE (53746-545-01) 53746-545-05 500 TABLET in 1 BOTTLE (53746-545-05) 53746-545-10 1000 TABLET in 1 BOTTLE (53746-545-10)

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": "ac6a300f-94ee-4b1c-9aaf-bce9b2c7781c", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0353746545015"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150"], "spl_set_id": ["3cdc361a-5558-4341-ad40-f8bc29b4f1ce"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-545-01)", "package_ndc": "53746-545-01", "marketing_start_date": "20091224"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-545-05)", "package_ndc": "53746-545-05", "marketing_start_date": "20091224"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53746-545-10)", "package_ndc": "53746-545-10", "marketing_start_date": "20091224"}], "brand_name": "Primidone", "product_id": "53746-545_ac6a300f-94ee-4b1c-9aaf-bce9b2c7781c", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "53746-545", "generic_name": "Primidone", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Primidone", "active_ingredients": [{"name": "PRIMIDONE", "strength": "250 mg/1"}], "application_number": "ANDA040866", "marketing_category": "ANDA", "marketing_start_date": "20091224", "listing_expiration_date": "20261231"}