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 POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

vigabatrin 50 mg/mL

Manufacturer
Lundbeck Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 67386-211
Product ID 67386-211_d2901195-e325-4ca5-8453-b020a77ba6aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022006
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 67386211
Hyphenated Format 67386-211

Supplemental Identifiers

RxCUI
250820 860898
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 NDA022006 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 50 PACKET in 1 CARTON (67386-211-65) / 10 mL in 1 PACKET
source: ndc

Packages (1)

67386-211-65 50 PACKET in 1 CARTON (67386-211-65) / 10 mL in 1 PACKET

Ingredients (1)

vigabatrin (50 mg/mL)

Linked Drug Pages (1)

SABRIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d2901195-e325-4ca5-8453-b020a77ba6aa", "openfda": {"nui": ["N0000175753"], "unii": ["GR120KRT6K"], "rxcui": ["250820", "860898"], "spl_set_id": ["a88ac1b4-e2c9-45c0-b321-4785902172e3"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Lundbeck Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (67386-211-65)  / 10 mL in 1 PACKET", "package_ndc": "67386-211-65", "marketing_start_date": "20090821"}], "brand_name": "SABRIL", "product_id": "67386-211_d2901195-e325-4ca5-8453-b020a77ba6aa", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "67386-211", "generic_name": "vigabatrin", "labeler_name": "Lundbeck Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SABRIL", "active_ingredients": [{"name": "VIGABATRIN", "strength": "50 mg/mL"}], "application_number": "NDA022006", "marketing_category": "NDA", "marketing_start_date": "20090821", "listing_expiration_date": "20261231"}