primidone

Generic: primidone

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler lannett company, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 50 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-1301
Product ID 0527-1301_99bd0a67-2742-43dd-9ddc-430b9141c3b1
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 05271301
Hyphenated Format 0527-1301

Supplemental Identifiers

RxCUI
96304 198150
UPC
0305871231011
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
  • 100 TABLET in 1 BOTTLE (0527-1301-01)
  • 500 TABLET in 1 BOTTLE (0527-1301-05)
  • 1000 TABLET in 1 BOTTLE (0527-1301-10)
source: ndc

Packages (3)

0527-1301-01 100 TABLET in 1 BOTTLE (0527-1301-01) 0527-1301-05 500 TABLET in 1 BOTTLE (0527-1301-05) 0527-1301-10 1000 TABLET in 1 BOTTLE (0527-1301-10)

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": "99bd0a67-2742-43dd-9ddc-430b9141c3b1", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0305871231011"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150"], "spl_set_id": ["a1a817f7-c190-4825-94eb-442f477187e3"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0527-1301-01)", "package_ndc": "0527-1301-01", "marketing_start_date": "20010524"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0527-1301-05)", "package_ndc": "0527-1301-05", "marketing_start_date": "20010524"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0527-1301-10)", "package_ndc": "0527-1301-10", "marketing_start_date": "20010524"}], "brand_name": "Primidone", "product_id": "0527-1301_99bd0a67-2742-43dd-9ddc-430b9141c3b1", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0527-1301", "generic_name": "Primidone", "labeler_name": "Lannett Company, Inc.", "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"}