vigpoder

Generic: vigabatrin

Labeler: pyros pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigpoder
Generic Name vigabatrin
Labeler pyros pharmaceuticals, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

vigabatrin 50 mg/mL

Manufacturer
Pyros Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 80789-117
Product ID 80789-117_05d784d4-cda0-428a-972f-d7191d86cba6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214961
Marketing Start 2024-02-15
Marketing End 2026-03-31

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80789117
Hyphenated Format 80789-117

Supplemental Identifiers

RxCUI
250820 2668482
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 vigpoder (source: ndc)
Generic Name vigabatrin (source: ndc)
Application Number ANDA214961 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 50 PACKET in 1 CARTON (80789-117-50) / 10 mL in 1 PACKET (80789-117-01)
source: ndc

Packages (1)

80789-117-50 50 PACKET in 1 CARTON (80789-117-50) / 10 mL in 1 PACKET (80789-117-01)

Ingredients (1)

vigabatrin (50 mg/mL)

Linked Drug Pages (1)

VIGPODER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "05d784d4-cda0-428a-972f-d7191d86cba6", "openfda": {"nui": ["N0000175753"], "unii": ["GR120KRT6K"], "rxcui": ["250820", "2668482"], "spl_set_id": ["1859a632-e98e-4152-b91d-b8aae1107be1"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Pyros Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (80789-117-50)  / 10 mL in 1 PACKET (80789-117-01)", "package_ndc": "80789-117-50", "marketing_end_date": "20260331", "marketing_start_date": "20240215"}], "brand_name": "VIGPODER", "product_id": "80789-117_05d784d4-cda0-428a-972f-d7191d86cba6", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "80789-117", "generic_name": "vigabatrin", "labeler_name": "Pyros Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIGPODER", "active_ingredients": [{"name": "VIGABATRIN", "strength": "50 mg/mL"}], "application_number": "ANDA214961", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20240215"}