primidone

Generic: primidone

Labeler: golden state medical supply, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler golden state medical supply, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 50 mg/1

Manufacturer
Golden State Medical Supply, Inc

Identifiers & Regulatory

Product NDC 51407-637
Product ID 51407-637_29f49f7f-d100-e0e1-e063-6394a90ac981
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 51407637
Hyphenated Format 51407-637

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 ANDA084903 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (51407-637-01)
  • 500 TABLET in 1 BOTTLE (51407-637-05)
source: ndc

Packages (2)

51407-637-01 100 TABLET in 1 BOTTLE (51407-637-01) 51407-637-05 500 TABLET in 1 BOTTLE (51407-637-05)

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": "29f49f7f-d100-e0e1-e063-6394a90ac981", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150"], "spl_set_id": ["e4e493bd-94d7-7e5a-e053-2995a90a2706"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Golden State Medical Supply, Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (51407-637-01)", "package_ndc": "51407-637-01", "marketing_start_date": "20220203"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (51407-637-05)", "package_ndc": "51407-637-05", "marketing_start_date": "20220203"}], "brand_name": "Primidone", "product_id": "51407-637_29f49f7f-d100-e0e1-e063-6394a90ac981", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "51407-637", "generic_name": "Primidone", "labeler_name": "Golden State Medical Supply, 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"}