sabril

Generic: vigabatrin

Labeler: lundbeck pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sabril
Generic Name vigabatrin
Labeler lundbeck pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

vigabatrin 500 mg/1

Manufacturer
Lundbeck Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 67386-111
Product ID 67386-111_09c27a1b-5916-4e16-a9a3-924099661be6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020427
Listing Expiration 2026-12-31
Marketing Start 2009-08-21

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67386111
Hyphenated Format 67386-111

Supplemental Identifiers

RxCUI
199521 860895
UPC
0367386111011
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 sabril (source: ndc)
Generic Name vigabatrin (source: ndc)
Application Number NDA020427 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (67386-111-01)
source: ndc

Packages (1)

67386-111-01 100 TABLET, FILM COATED in 1 BOTTLE (67386-111-01)

Ingredients (1)

vigabatrin (500 mg/1)

Linked Drug Pages (1)

SABRIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "09c27a1b-5916-4e16-a9a3-924099661be6", "openfda": {"nui": ["N0000175753"], "upc": ["0367386111011"], "unii": ["GR120KRT6K"], "rxcui": ["199521", "860895"], "spl_set_id": ["a5d389d2-d0e1-4395-a2a2-b552808e7f98"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Lundbeck Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (67386-111-01)", "package_ndc": "67386-111-01", "marketing_start_date": "20090821"}], "brand_name": "SABRIL", "product_id": "67386-111_09c27a1b-5916-4e16-a9a3-924099661be6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "67386-111", "generic_name": "vigabatrin", "labeler_name": "Lundbeck Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SABRIL", "active_ingredients": [{"name": "VIGABATRIN", "strength": "500 mg/1"}], "application_number": "NDA020427", "marketing_category": "NDA", "marketing_start_date": "20090821", "listing_expiration_date": "20261231"}