methsuximide

Generic: methsuximide

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

Drug Facts

Product Profile

Brand Name methsuximide
Generic Name methsuximide
Labeler ani pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

methsuximide 300 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-228
Product ID 70954-228_5138e347-665b-4dd6-b9f8-12f4a807ed4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217213
Listing Expiration 2026-12-31
Marketing Start 2023-05-01

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 70954228
Hyphenated Format 70954-228

Supplemental Identifiers

RxCUI
197949
UPC
0370954228103
UNII
0G76K8X6C0
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 methsuximide (source: ndc)
Generic Name methsuximide (source: ndc)
Application Number ANDA217213 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (70954-228-10)
source: ndc

Packages (1)

70954-228-10 100 CAPSULE in 1 BOTTLE (70954-228-10)

Ingredients (1)

methsuximide (300 mg/1)

Linked Drug Pages (1)

Methsuximide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5138e347-665b-4dd6-b9f8-12f4a807ed4e", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0370954228103"], "unii": ["0G76K8X6C0"], "rxcui": ["197949"], "spl_set_id": ["5138e347-665b-4dd6-b9f8-12f4a807ed4e"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (70954-228-10)", "package_ndc": "70954-228-10", "marketing_start_date": "20230501"}], "brand_name": "Methsuximide", "product_id": "70954-228_5138e347-665b-4dd6-b9f8-12f4a807ed4e", "dosage_form": "CAPSULE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70954-228", "generic_name": "Methsuximide", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methsuximide", "active_ingredients": [{"name": "METHSUXIMIDE", "strength": "300 mg/1"}], "application_number": "ANDA217213", "marketing_category": "ANDA", "marketing_start_date": "20230501", "listing_expiration_date": "20261231"}