ethosuximide

Generic: ethosuximide

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ethosuximide
Generic Name ethosuximide
Labeler mylan pharmaceuticals inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

ethosuximide 250 mg/5mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-2350
Product ID 59762-2350_51ec0774-2e64-4b64-8da7-7672e6e77736
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080258
Listing Expiration 2026-12-31
Marketing Start 2020-02-21

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 597622350
Hyphenated Format 59762-2350

Supplemental Identifiers

RxCUI
251322
UNII
5SEH9X1D1D
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 ethosuximide (source: ndc)
Generic Name ethosuximide (source: ndc)
Application Number ANDA080258 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (59762-2350-6) / 474 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (59762-2350-7) / 474 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

59762-2350-6 1 BOTTLE, PLASTIC in 1 CARTON (59762-2350-6) / 474 mL in 1 BOTTLE, PLASTIC 59762-2350-7 1 BOTTLE, PLASTIC in 1 CARTON (59762-2350-7) / 474 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

ethosuximide (250 mg/5mL)

Linked Drug Pages (1)

Ethosuximide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "51ec0774-2e64-4b64-8da7-7672e6e77736", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["5SEH9X1D1D"], "rxcui": ["251322"], "spl_set_id": ["19c924c2-f558-4c78-9277-2d7e0df2f505"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (59762-2350-6)  / 474 mL in 1 BOTTLE, PLASTIC", "package_ndc": "59762-2350-6", "marketing_start_date": "20200221"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (59762-2350-7)  / 474 mL in 1 BOTTLE, PLASTIC", "package_ndc": "59762-2350-7", "marketing_start_date": "20220701"}], "brand_name": "Ethosuximide", "product_id": "59762-2350_51ec0774-2e64-4b64-8da7-7672e6e77736", "dosage_form": "SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "59762-2350", "generic_name": "Ethosuximide", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ethosuximide", "active_ingredients": [{"name": "ETHOSUXIMIDE", "strength": "250 mg/5mL"}], "application_number": "ANDA080258", "marketing_category": "ANDA", "marketing_start_date": "20200221", "listing_expiration_date": "20261231"}