primidone

Generic: primidone

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

Drug Facts

Product Profile

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

primidone 250 mg/1

Manufacturer
Carnegie Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 80005-118
Product ID 80005-118_1f77f842-e0b6-4659-beee-0bb01da839e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218366
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

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 80005118
Hyphenated Format 80005-118

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 ANDA218366 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (80005-118-11)
  • 500 TABLET in 1 BOTTLE (80005-118-14)
  • 1000 TABLET in 1 BOTTLE (80005-118-15)
source: ndc

Packages (3)

80005-118-11 100 TABLET in 1 BOTTLE (80005-118-11) 80005-118-14 500 TABLET in 1 BOTTLE (80005-118-14) 80005-118-15 1000 TABLET in 1 BOTTLE (80005-118-15)

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": "1f77f842-e0b6-4659-beee-0bb01da839e3", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150"], "spl_set_id": ["dc018b1d-72d3-45a2-84ff-cf9499c7ae97"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Carnegie Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (80005-118-11)", "package_ndc": "80005-118-11", "marketing_start_date": "20240501"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (80005-118-14)", "package_ndc": "80005-118-14", "marketing_start_date": "20240501"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (80005-118-15)", "package_ndc": "80005-118-15", "marketing_start_date": "20240501"}], "brand_name": "Primidone", "product_id": "80005-118_1f77f842-e0b6-4659-beee-0bb01da839e3", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "80005-118", "generic_name": "Primidone", "labeler_name": "Carnegie Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Primidone", "active_ingredients": [{"name": "PRIMIDONE", "strength": "250 mg/1"}], "application_number": "ANDA218366", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}