primidone

Generic: primidone

Labeler: trupharma llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler trupharma llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 125 mg/1

Manufacturer
TruPharma LLC.

Identifiers & Regulatory

Product NDC 52817-117
Product ID 52817-117_f6667426-b68b-1ac7-e053-2a95a90a905b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214896
Listing Expiration 2026-12-31
Marketing Start 2022-06-28

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 52817117
Hyphenated Format 52817-117

Supplemental Identifiers

RxCUI
328176
UPC
0352817117106 0352817117502
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 ANDA214896 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (52817-117-10)
  • 30 TABLET in 1 BOTTLE (52817-117-30)
  • 500 TABLET in 1 BOTTLE (52817-117-50)
source: ndc

Packages (3)

52817-117-10 100 TABLET in 1 BOTTLE (52817-117-10) 52817-117-30 30 TABLET in 1 BOTTLE (52817-117-30) 52817-117-50 500 TABLET in 1 BOTTLE (52817-117-50)

Ingredients (1)

primidone (125 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": "f6667426-b68b-1ac7-e053-2a95a90a905b", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0352817117106", "0352817117502"], "unii": ["13AFD7670Q"], "rxcui": ["328176"], "spl_set_id": ["c60b3a92-4404-4a89-b2c5-c23ff72bedad"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["TruPharma LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (52817-117-10)", "package_ndc": "52817-117-10", "marketing_start_date": "20230221"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (52817-117-30)", "package_ndc": "52817-117-30", "marketing_start_date": "20230221"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (52817-117-50)", "package_ndc": "52817-117-50", "marketing_start_date": "20230221"}], "brand_name": "Primidone", "product_id": "52817-117_f6667426-b68b-1ac7-e053-2a95a90a905b", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "52817-117", "generic_name": "Primidone", "labeler_name": "TruPharma LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Primidone", "active_ingredients": [{"name": "PRIMIDONE", "strength": "125 mg/1"}], "application_number": "ANDA214896", "marketing_category": "ANDA", "marketing_start_date": "20220628", "listing_expiration_date": "20261231"}