vigabatrin

Generic: vigabatrin

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigabatrin
Generic Name vigabatrin
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

vigabatrin 500 mg/10mL

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 70710-1494
Product ID 70710-1494_b41c9be1-67c2-416e-ae53-5c31eafb8e10
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214671
Listing Expiration 2026-12-31
Marketing Start 2025-03-24

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101494
Hyphenated Format 70710-1494

Supplemental Identifiers

RxCUI
250820
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 ANDA214671 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 50 PACKET in 1 CARTON (70710-1494-8) / 10 mL in 1 PACKET (70710-1494-1)
source: ndc

Packages (1)

70710-1494-8 50 PACKET in 1 CARTON (70710-1494-8) / 10 mL in 1 PACKET (70710-1494-1)

Ingredients (1)

vigabatrin (500 mg/10mL)

Linked Drug Pages (1)

vigabatrin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b41c9be1-67c2-416e-ae53-5c31eafb8e10", "openfda": {"nui": ["N0000175753"], "unii": ["GR120KRT6K"], "rxcui": ["250820"], "spl_set_id": ["6d3fc853-1b2d-47ad-a4f2-f11505601bc2"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (70710-1494-8)  / 10 mL in 1 PACKET (70710-1494-1)", "package_ndc": "70710-1494-8", "marketing_start_date": "20250324"}], "brand_name": "vigabatrin", "product_id": "70710-1494_b41c9be1-67c2-416e-ae53-5c31eafb8e10", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "70710-1494", "generic_name": "vigabatrin", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "vigabatrin", "active_ingredients": [{"name": "VIGABATRIN", "strength": "500 mg/10mL"}], "application_number": "ANDA214671", "marketing_category": "ANDA", "marketing_start_date": "20250324", "listing_expiration_date": "20261231"}