primidone

Generic: primidone

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-178
Product ID 72789-178_419df69c-92e1-79f5-e063-6294a90a3e68
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040586
Listing Expiration 2026-12-31
Marketing Start 2021-02-22

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 72789178
Hyphenated Format 72789-178

Supplemental Identifiers

RxCUI
96304 198150
UPC
0372789178820 0372789177823
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
  • 100 TABLET in 1 BOTTLE, PLASTIC (72789-178-01)
  • 500 TABLET in 1 BOTTLE, PLASTIC (72789-178-82)
source: ndc

Packages (2)

72789-178-01 100 TABLET in 1 BOTTLE, PLASTIC (72789-178-01) 72789-178-82 500 TABLET in 1 BOTTLE, PLASTIC (72789-178-82)

Ingredients (1)

primidone (50 mg/1)

Linked Drug Pages (2)

Primidone ndc-match (0.9) Primidone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "419df69c-92e1-79f5-e063-6294a90a3e68", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0372789178820", "0372789177823"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150"], "spl_set_id": ["6046e4e9-0c1e-4d1f-85fa-d2ce25c5dc34"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (72789-178-01)", "package_ndc": "72789-178-01", "marketing_start_date": "20210330"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (72789-178-82)", "package_ndc": "72789-178-82", "marketing_start_date": "20210622"}], "brand_name": "Primidone", "product_id": "72789-178_419df69c-92e1-79f5-e063-6294a90a3e68", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72789-178", "generic_name": "Primidone", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20210222", "listing_expiration_date": "20261231"}