vigabatrin

Generic: vigabatrin

Labeler: edenbridge pharmaceuticals llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigabatrin
Generic Name vigabatrin
Labeler edenbridge pharmaceuticals llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

vigabatrin 500 mg/1

Manufacturer
Edenbridge Pharmaceuticals LLC.

Identifiers & Regulatory

Product NDC 42799-950
Product ID 42799-950_93ba3894-fd97-4432-9f2d-e7050371e91f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215109
Listing Expiration 2026-12-31
Marketing Start 2022-06-29

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42799950
Hyphenated Format 42799-950

Supplemental Identifiers

RxCUI
199521
UNII
GR120KRT6K
NUI
N0000175753

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 vigabatrin (source: ndc)
Generic Name vigabatrin (source: ndc)
Application Number ANDA215109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42799-950-01)
source: ndc

Packages (1)

42799-950-01 100 TABLET in 1 BOTTLE (42799-950-01)

Ingredients (1)

vigabatrin (500 mg/1)

Linked Drug Pages (1)

Vigabatrin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "93ba3894-fd97-4432-9f2d-e7050371e91f", "openfda": {"nui": ["N0000175753"], "unii": ["GR120KRT6K"], "rxcui": ["199521"], "spl_set_id": ["93ba3894-fd97-4432-9f2d-e7050371e91f"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Edenbridge Pharmaceuticals LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42799-950-01)", "package_ndc": "42799-950-01", "marketing_start_date": "20220629"}], "brand_name": "Vigabatrin", "product_id": "42799-950_93ba3894-fd97-4432-9f2d-e7050371e91f", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "42799-950", "generic_name": "Vigabatrin", "labeler_name": "Edenbridge Pharmaceuticals LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vigabatrin", "active_ingredients": [{"name": "VIGABATRIN", "strength": "500 mg/1"}], "application_number": "ANDA215109", "marketing_category": "ANDA", "marketing_start_date": "20220629", "listing_expiration_date": "20261231"}