vigabatrin

Generic: vigabatrin

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigabatrin
Generic Name vigabatrin
Labeler novadoz pharmaceuticals llc
Dosage Form FOR SOLUTION
Routes
ORAL
Active Ingredients

vigabatrin 50 mg/mL

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-093
Product ID 72205-093_082d818a-4f4e-4675-98c6-91db0294e63c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215363
Listing Expiration 2026-12-31
Marketing Start 2022-09-07

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205093
Hyphenated Format 72205-093

Supplemental Identifiers

RxCUI
250820
UPC
0372205093508
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 vigabatrin (source: ndc)
Generic Name vigabatrin (source: ndc)
Application Number ANDA215363 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 50 PACKET in 1 CARTON (72205-093-50) / 10 mL in 1 PACKET (72205-093-61)
source: ndc

Packages (1)

72205-093-50 50 PACKET in 1 CARTON (72205-093-50) / 10 mL in 1 PACKET (72205-093-61)

Ingredients (1)

vigabatrin (50 mg/mL)

Linked Drug Pages (1)

Vigabatrin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "082d818a-4f4e-4675-98c6-91db0294e63c", "openfda": {"nui": ["N0000175753"], "upc": ["0372205093508"], "unii": ["GR120KRT6K"], "rxcui": ["250820"], "spl_set_id": ["082d818a-4f4e-4675-98c6-91db0294e63c"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (72205-093-50)  / 10 mL in 1 PACKET (72205-093-61)", "package_ndc": "72205-093-50", "marketing_start_date": "20220908"}], "brand_name": "Vigabatrin", "product_id": "72205-093_082d818a-4f4e-4675-98c6-91db0294e63c", "dosage_form": "FOR SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "72205-093", "generic_name": "vigabatrin", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vigabatrin", "active_ingredients": [{"name": "VIGABATRIN", "strength": "50 mg/mL"}], "application_number": "ANDA215363", "marketing_category": "ANDA", "marketing_start_date": "20220907", "listing_expiration_date": "20261231"}