primidone

Generic: primidone

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 250 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-687
Product ID 50268-687_42dc4ff9-003f-d362-e063-6394a90ad6f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040866
Listing Expiration 2026-12-31
Marketing Start 2011-05-19

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 50268687
Hyphenated Format 50268-687

Supplemental Identifiers

RxCUI
96304 198150
UNII
13AFD7670Q
NUI
N0000175753 N0000008486

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 ANDA040866 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-687-15) / 1 TABLET in 1 BLISTER PACK (50268-687-11)
source: ndc

Packages (1)

50268-687-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-687-15) / 1 TABLET in 1 BLISTER PACK (50268-687-11)

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": "42dc4ff9-003f-d362-e063-6394a90ad6f9", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150"], "spl_set_id": ["a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-687-15)  / 1 TABLET in 1 BLISTER PACK (50268-687-11)", "package_ndc": "50268-687-15", "marketing_start_date": "20110519"}], "brand_name": "Primidone", "product_id": "50268-687_42dc4ff9-003f-d362-e063-6394a90ad6f9", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50268-687", "generic_name": "Primidone", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Primidone", "active_ingredients": [{"name": "PRIMIDONE", "strength": "250 mg/1"}], "application_number": "ANDA040866", "marketing_category": "ANDA", "marketing_start_date": "20110519", "listing_expiration_date": "20261231"}