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 POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

vigabatrin 50 mg/mL

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0245-0556
Product ID 0245-0556_3aae9c74-44ec-cc53-e063-6294a90a5538
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210196
Listing Expiration 2026-12-31
Marketing Start 2018-06-21

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02450556
Hyphenated Format 0245-0556

Supplemental Identifiers

RxCUI
250820 2047868
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 ANDA210196 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 50 PACKET in 1 CARTON (0245-0556-50) / 10 mL in 1 PACKET (0245-0556-89)
source: ndc

Packages (1)

0245-0556-50 50 PACKET in 1 CARTON (0245-0556-50) / 10 mL in 1 PACKET (0245-0556-89)

Ingredients (1)

vigabatrin (50 mg/mL)

Linked Drug Pages (1)

VIGADRONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3aae9c74-44ec-cc53-e063-6294a90a5538", "openfda": {"nui": ["N0000175753"], "unii": ["GR120KRT6K"], "rxcui": ["250820", "2047868"], "spl_set_id": ["5e5e7554-d0f4-47f7-a434-cc5ca5a9826f"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (0245-0556-50)  / 10 mL in 1 PACKET (0245-0556-89)", "package_ndc": "0245-0556-50", "marketing_start_date": "20180621"}], "brand_name": "VIGADRONE", "product_id": "0245-0556_3aae9c74-44ec-cc53-e063-6294a90a5538", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "0245-0556", "generic_name": "vigabatrin", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIGADRONE", "active_ingredients": [{"name": "VIGABATRIN", "strength": "50 mg/mL"}], "application_number": "ANDA210196", "marketing_category": "ANDA", "marketing_start_date": "20180621", "listing_expiration_date": "20261231"}