primidone

Generic: primidone

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 250 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-5321
Product ID 0591-5321_237e4801-0ed5-4e50-a128-52f580f0b6d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083551
Listing Expiration 2026-12-31
Marketing Start 2010-06-19

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 05915321
Hyphenated Format 0591-5321

Supplemental Identifiers

RxCUI
96304
UPC
0305915321012
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 ANDA083551 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0591-5321-01)
source: ndc

Packages (1)

0591-5321-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-5321-01)

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": "237e4801-0ed5-4e50-a128-52f580f0b6d7", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0305915321012"], "unii": ["13AFD7670Q"], "rxcui": ["96304"], "spl_set_id": ["ae0fa704-818e-4423-8e3a-6cc3390cdd7d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0591-5321-01)", "package_ndc": "0591-5321-01", "marketing_start_date": "20100619"}], "brand_name": "Primidone", "product_id": "0591-5321_237e4801-0ed5-4e50-a128-52f580f0b6d7", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0591-5321", "generic_name": "Primidone", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Primidone", "active_ingredients": [{"name": "PRIMIDONE", "strength": "250 mg/1"}], "application_number": "ANDA083551", "marketing_category": "ANDA", "marketing_start_date": "20100619", "listing_expiration_date": "20261231"}