vigadrone

Generic: vigabatrin

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigadrone
Generic Name vigabatrin
Labeler upsher-smith laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

vigabatrin 500 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0245-6001
Product ID 0245-6001_2734e899-4ddc-836c-e063-6294a90a128f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214749
Listing Expiration 2026-12-31
Marketing Start 2023-06-29

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02456001
Hyphenated Format 0245-6001

Supplemental Identifiers

RxCUI
199521 2642353
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 vigadrone (source: ndc)
Generic Name vigabatrin (source: ndc)
Application Number ANDA214749 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0245-6001-11) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (1)

0245-6001-11 1 BOTTLE in 1 CARTON (0245-6001-11) / 100 TABLET in 1 BOTTLE

Ingredients (1)

vigabatrin (500 mg/1)

Linked Drug Pages (1)

VIGADRONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2734e899-4ddc-836c-e063-6294a90a128f", "openfda": {"nui": ["N0000175753"], "unii": ["GR120KRT6K"], "rxcui": ["199521", "2642353"], "spl_set_id": ["01f7f049-78c2-47c2-a66e-ec662ba48a98"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0245-6001-11)  / 100 TABLET in 1 BOTTLE", "package_ndc": "0245-6001-11", "marketing_start_date": "20230630"}], "brand_name": "VIGADRONE", "product_id": "0245-6001_2734e899-4ddc-836c-e063-6294a90a128f", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "0245-6001", "generic_name": "Vigabatrin", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIGADRONE", "active_ingredients": [{"name": "VIGABATRIN", "strength": "500 mg/1"}], "application_number": "ANDA214749", "marketing_category": "ANDA", "marketing_start_date": "20230629", "listing_expiration_date": "20261231"}