primidone

Generic: primidone

Labeler: advagen pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler advagen pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 125 mg/1

Manufacturer
Advagen Pharma Limited

Identifiers & Regulatory

Product NDC 72888-160
Product ID 72888-160_48453b30-812c-76c6-e063-6394a90ad9a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214896
Listing Expiration 2027-12-31
Marketing Start 2022-06-28

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 72888160
Hyphenated Format 72888-160

Supplemental Identifiers

RxCUI
96304 198150 328176
UPC
0372888160016 0372888046051 0372888160009 0372888046013 0372888045054 0372888160054 0372888045016
UNII
13AFD7670Q
NUI
N0000175753 N0000008486

Packaging Origin

Original Packager
true

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 ANDA214896 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (72888-160-00)
  • 100 TABLET in 1 BOTTLE (72888-160-01)
  • 500 TABLET in 1 BOTTLE (72888-160-05)
  • 30 TABLET in 1 BOTTLE (72888-160-30)
source: ndc

Packages (4)

72888-160-00 1000 TABLET in 1 BOTTLE (72888-160-00) 72888-160-01 100 TABLET in 1 BOTTLE (72888-160-01) 72888-160-05 500 TABLET in 1 BOTTLE (72888-160-05) 72888-160-30 30 TABLET in 1 BOTTLE (72888-160-30)

Ingredients (1)

primidone (125 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": "48453b30-812c-76c6-e063-6394a90ad9a0", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0372888160016", "0372888046051", "0372888160009", "0372888046013", "0372888045054", "0372888160054", "0372888045016"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150", "328176"], "spl_set_id": ["b3b94d2e-6a64-45b7-b0cb-0fde689240d8"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Advagen Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (72888-160-00)", "package_ndc": "72888-160-00", "marketing_start_date": "20220628"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (72888-160-01)", "package_ndc": "72888-160-01", "marketing_start_date": "20220628"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72888-160-05)", "package_ndc": "72888-160-05", "marketing_start_date": "20220628"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72888-160-30)", "package_ndc": "72888-160-30", "marketing_start_date": "20220628"}], "brand_name": "Primidone", "product_id": "72888-160_48453b30-812c-76c6-e063-6394a90ad9a0", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72888-160", "generic_name": "Primidone", "labeler_name": "Advagen Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Primidone", "active_ingredients": [{"name": "PRIMIDONE", "strength": "125 mg/1"}], "application_number": "ANDA214896", "marketing_category": "ANDA", "marketing_start_date": "20220628", "listing_expiration_date": "20271231"}