primidone

Generic: primidone

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

primidone 50 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-509
Product ID 42291-509_485f9eb1-6531-c47c-e063-6394a90ae32c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040866
Listing Expiration 2027-12-31
Marketing Start 2022-03-22

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 42291509
Hyphenated Format 42291-509

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
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42291-509-01)
  • 500 TABLET in 1 BOTTLE (42291-509-50)
source: ndc

Packages (2)

42291-509-01 100 TABLET in 1 BOTTLE (42291-509-01) 42291-509-50 500 TABLET in 1 BOTTLE (42291-509-50)

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": "485f9eb1-6531-c47c-e063-6394a90ae32c", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150"], "spl_set_id": ["e7a50a67-9653-463e-8c85-315b53f460c8"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42291-509-01)", "package_ndc": "42291-509-01", "marketing_start_date": "20220322"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (42291-509-50)", "package_ndc": "42291-509-50", "marketing_start_date": "20220322"}], "brand_name": "Primidone", "product_id": "42291-509_485f9eb1-6531-c47c-e063-6394a90ae32c", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "42291-509", "generic_name": "Primidone", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Primidone", "active_ingredients": [{"name": "PRIMIDONE", "strength": "50 mg/1"}], "application_number": "ANDA040866", "marketing_category": "ANDA", "marketing_start_date": "20220322", "listing_expiration_date": "20271231"}