vigafyde

Generic: vigabatrin

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

Drug Facts

Product Profile

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

vigabatrin 100 mg/mL

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 80789-003
Product ID 80789-003_43aeb38a-b4ee-47ed-8239-c488b074f1c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217684
Listing Expiration 2027-12-31
Marketing Start 2024-06-18

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80789003
Hyphenated Format 80789-003

Supplemental Identifiers

RxCUI
2685217 2685223
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 vigafyde (source: ndc)
Generic Name vigabatrin (source: ndc)
Application Number NDA217684 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (80789-003-15) / 150 mL in 1 BOTTLE
source: ndc

Packages (1)

80789-003-15 1 BOTTLE in 1 CARTON (80789-003-15) / 150 mL in 1 BOTTLE

Ingredients (1)

vigabatrin (100 mg/mL)

Linked Drug Pages (1)

VIGAFYDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43aeb38a-b4ee-47ed-8239-c488b074f1c9", "openfda": {"nui": ["N0000175753"], "unii": ["GR120KRT6K"], "rxcui": ["2685217", "2685223"], "spl_set_id": ["8d3d6316-33ab-41e8-9485-4495c218be56"], "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 (80789-003-15)  / 150 mL in 1 BOTTLE", "package_ndc": "80789-003-15", "marketing_start_date": "20240826"}], "brand_name": "VIGAFYDE", "product_id": "80789-003_43aeb38a-b4ee-47ed-8239-c488b074f1c9", "dosage_form": "SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "80789-003", "generic_name": "vigabatrin", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIGAFYDE", "active_ingredients": [{"name": "VIGABATRIN", "strength": "100 mg/mL"}], "application_number": "NDA217684", "marketing_category": "NDA", "marketing_start_date": "20240618", "listing_expiration_date": "20271231"}