primidone

Generic: primidone

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name primidone
Generic Name primidone
Labeler dr. reddy's laboratories limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

primidone 250 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-476
Product ID 55111-476_6f5c36d3-3f99-803c-5be6-66b2e1058946
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040862
Listing Expiration 2026-12-31
Marketing Start 2008-10-03

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 55111476
Hyphenated Format 55111-476

Supplemental Identifiers

RxCUI
96304 198150
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 ANDA040862 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (55111-476-01)
  • 500 TABLET in 1 BOTTLE (55111-476-05)
  • 30 TABLET in 1 BOTTLE (55111-476-30)
  • 60 TABLET in 1 BOTTLE (55111-476-60)
  • 10 BLISTER PACK in 1 CARTON (55111-476-78) / 10 TABLET in 1 BLISTER PACK (55111-476-79)
source: ndc

Packages (5)

55111-476-01 100 TABLET in 1 BOTTLE (55111-476-01) 55111-476-05 500 TABLET in 1 BOTTLE (55111-476-05) 55111-476-30 30 TABLET in 1 BOTTLE (55111-476-30) 55111-476-60 60 TABLET in 1 BOTTLE (55111-476-60) 55111-476-78 10 BLISTER PACK in 1 CARTON (55111-476-78) / 10 TABLET in 1 BLISTER PACK (55111-476-79)

Ingredients (1)

primidone (250 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": "6f5c36d3-3f99-803c-5be6-66b2e1058946", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["13AFD7670Q"], "rxcui": ["96304", "198150"], "spl_set_id": ["a4f917f4-2aa2-c3ed-071e-232fa0f125e8"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (55111-476-01)", "package_ndc": "55111-476-01", "marketing_start_date": "20081003"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (55111-476-05)", "package_ndc": "55111-476-05", "marketing_start_date": "20081003"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (55111-476-30)", "package_ndc": "55111-476-30", "marketing_start_date": "20081003"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (55111-476-60)", "package_ndc": "55111-476-60", "marketing_start_date": "20081003"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-476-78)  / 10 TABLET in 1 BLISTER PACK (55111-476-79)", "package_ndc": "55111-476-78", "marketing_start_date": "20081003"}], "brand_name": "Primidone", "product_id": "55111-476_6f5c36d3-3f99-803c-5be6-66b2e1058946", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "55111-476", "generic_name": "Primidone", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Primidone", "active_ingredients": [{"name": "PRIMIDONE", "strength": "250 mg/1"}], "application_number": "ANDA040862", "marketing_category": "ANDA", "marketing_start_date": "20081003", "listing_expiration_date": "20261231"}