primidone

Generic: primidone

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

primidone 50 mg/1

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 72189-216
Product ID 72189-216_2be9877c-0b1e-23b4-e063-6394a90af68f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040586
Listing Expiration 2026-12-31
Marketing Start 2021-05-11

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 72189216
Hyphenated Format 72189-216

Supplemental Identifiers

RxCUI
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 ANDA040586 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (72189-216-60)
source: ndc

Packages (1)

72189-216-60 60 TABLET in 1 BOTTLE (72189-216-60)

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": "2be9877c-0b1e-23b4-e063-6394a90af68f", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["13AFD7670Q"], "rxcui": ["198150"], "spl_set_id": ["c20f803c-e965-9dd8-e053-2995a90a92ba"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-216-60)", "package_ndc": "72189-216-60", "marketing_start_date": "20210511"}], "brand_name": "PRIMIDONE", "product_id": "72189-216_2be9877c-0b1e-23b4-e063-6394a90af68f", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72189-216", "generic_name": "PRIMIDONE", "labeler_name": "DIRECT RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRIMIDONE", "active_ingredients": [{"name": "PRIMIDONE", "strength": "50 mg/1"}], "application_number": "ANDA040586", "marketing_category": "ANDA", "marketing_start_date": "20210511", "listing_expiration_date": "20261231"}