primidone

Generic: primidone

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

Drug Facts

Product Profile

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

primidone 50 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-468
Product ID 62135-468_45ae0446-2685-d868-e063-6394a90ab581
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084903
Listing Expiration 2026-12-31
Marketing Start 2001-05-24

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 62135468
Hyphenated Format 62135-468

Supplemental Identifiers

RxCUI
198150
UPC
0362135468903
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 ANDA084903 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (62135-468-90)
source: ndc

Packages (1)

62135-468-90 90 TABLET in 1 BOTTLE (62135-468-90)

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": "45ae0446-2685-d868-e063-6394a90ab581", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0362135468903"], "unii": ["13AFD7670Q"], "rxcui": ["198150"], "spl_set_id": ["4a8e309f-d89e-4b1a-abb2-856a66ebbff9"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-468-90)", "package_ndc": "62135-468-90", "marketing_start_date": "20230411"}], "brand_name": "Primidone", "product_id": "62135-468_45ae0446-2685-d868-e063-6394a90ab581", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "62135-468", "generic_name": "Primidone", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Primidone", "active_ingredients": [{"name": "PRIMIDONE", "strength": "50 mg/1"}], "application_number": "ANDA084903", "marketing_category": "ANDA", "marketing_start_date": "20010524", "listing_expiration_date": "20261231"}