primidone

Generic: primidone

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 50 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-540
Product ID 71610-540_11c79cec-987d-4bce-b8ce-ba3edbe60dc6
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 71610540
Hyphenated Format 71610-540

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
  • 9000 TABLET in 1 BOTTLE, PLASTIC (71610-540-09)
  • 90 TABLET in 1 BOTTLE, PLASTIC (71610-540-60)
  • 180 TABLET in 1 BOTTLE, PLASTIC (71610-540-80)
  • 270 TABLET in 1 BOTTLE, PLASTIC (71610-540-92)
  • 360 TABLET in 1 BOTTLE, PLASTIC (71610-540-94)
source: ndc

Packages (5)

71610-540-09 9000 TABLET in 1 BOTTLE, PLASTIC (71610-540-09) 71610-540-60 90 TABLET in 1 BOTTLE, PLASTIC (71610-540-60) 71610-540-80 180 TABLET in 1 BOTTLE, PLASTIC (71610-540-80) 71610-540-92 270 TABLET in 1 BOTTLE, PLASTIC (71610-540-92) 71610-540-94 360 TABLET in 1 BOTTLE, PLASTIC (71610-540-94)

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": "11c79cec-987d-4bce-b8ce-ba3edbe60dc6", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["13AFD7670Q"], "rxcui": ["198150"], "spl_set_id": ["91de277e-34b8-4ee1-8846-f02aea626089"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 TABLET in 1 BOTTLE, PLASTIC (71610-540-09)", "package_ndc": "71610-540-09", "marketing_start_date": "20210628"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (71610-540-60)", "package_ndc": "71610-540-60", "marketing_start_date": "20210406"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (71610-540-80)", "package_ndc": "71610-540-80", "marketing_start_date": "20210406"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE, PLASTIC (71610-540-92)", "package_ndc": "71610-540-92", "marketing_start_date": "20210406"}, {"sample": false, "description": "360 TABLET in 1 BOTTLE, PLASTIC (71610-540-94)", "package_ndc": "71610-540-94", "marketing_start_date": "20210920"}], "brand_name": "Primidone", "product_id": "71610-540_11c79cec-987d-4bce-b8ce-ba3edbe60dc6", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-540", "generic_name": "Primidone", "labeler_name": "Aphena Pharma Solutions - Tennessee, 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"}