primidone

Generic: primidone

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler northstar rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 250 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 72603-610
Product ID 72603-610_35a3d3c5-7ece-bbd8-e063-6394a90a14aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214896
Listing Expiration 2026-12-31
Marketing Start 2025-05-01

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 72603610
Hyphenated Format 72603-610

Supplemental Identifiers

RxCUI
96304 198150
UPC
0372603609028 0372603609011 0372603610017
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
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72603-610-01)
source: ndc

Packages (1)

72603-610-01 100 TABLET in 1 BOTTLE (72603-610-01)

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": "35a3d3c5-7ece-bbd8-e063-6394a90a14aa", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0372603609028", "0372603609011", "0372603610017"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150"], "spl_set_id": ["182a424b-d142-48c9-996b-059c0885f528"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72603-610-01)", "package_ndc": "72603-610-01", "marketing_start_date": "20250501"}], "brand_name": "Primidone", "product_id": "72603-610_35a3d3c5-7ece-bbd8-e063-6394a90a14aa", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72603-610", "generic_name": "Primidone", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Primidone", "active_ingredients": [{"name": "PRIMIDONE", "strength": "250 mg/1"}], "application_number": "ANDA214896", "marketing_category": "ANDA", "marketing_start_date": "20250501", "listing_expiration_date": "20261231"}