primidone

Generic: primidone

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 50 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-202
Product ID 68084-202_23950268-33a3-8f1e-e063-6394a90a736a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084903
Listing Expiration 2026-12-31
Marketing Start 2007-09-05

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 68084202
Hyphenated Format 68084-202

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 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-202-01) / 1 TABLET in 1 BLISTER PACK (68084-202-11)
source: ndc

Packages (1)

68084-202-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-202-01) / 1 TABLET in 1 BLISTER PACK (68084-202-11)

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": "23950268-33a3-8f1e-e063-6394a90a736a", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150"], "spl_set_id": ["a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-202-01)  / 1 TABLET in 1 BLISTER PACK (68084-202-11)", "package_ndc": "68084-202-01", "marketing_start_date": "20070905"}], "brand_name": "Primidone", "product_id": "68084-202_23950268-33a3-8f1e-e063-6394a90a736a", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68084-202", "generic_name": "Primidone", "labeler_name": "American Health Packaging", "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": "20070905", "listing_expiration_date": "20261231"}