primidone

Generic: primidone

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 50 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1965
Product ID 71335-1965_5f5bb283-9a75-49c5-8537-9cd1270c22ee
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 713351965
Hyphenated Format 71335-1965

Supplemental Identifiers

RxCUI
198150
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
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (71335-1965-1)
  • 90 TABLET in 1 BOTTLE, PLASTIC (71335-1965-2)
  • 60 TABLET in 1 BOTTLE, PLASTIC (71335-1965-3)
source: ndc

Packages (3)

71335-1965-1 30 TABLET in 1 BOTTLE, PLASTIC (71335-1965-1) 71335-1965-2 90 TABLET in 1 BOTTLE, PLASTIC (71335-1965-2) 71335-1965-3 60 TABLET in 1 BOTTLE, PLASTIC (71335-1965-3)

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": "5f5bb283-9a75-49c5-8537-9cd1270c22ee", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["13AFD7670Q"], "rxcui": ["198150"], "spl_set_id": ["5067ff85-07f5-424c-b072-6907891e7b4e"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (71335-1965-1)", "package_ndc": "71335-1965-1", "marketing_start_date": "20220503"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (71335-1965-2)", "package_ndc": "71335-1965-2", "marketing_start_date": "20211004"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (71335-1965-3)", "package_ndc": "71335-1965-3", "marketing_start_date": "20220503"}], "brand_name": "Primidone", "product_id": "71335-1965_5f5bb283-9a75-49c5-8537-9cd1270c22ee", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71335-1965", "generic_name": "Primidone", "labeler_name": "Bryant Ranch Prepack", "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"}