vigabatrin

Generic: vigabatrin

Labeler: cipla usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigabatrin
Generic Name vigabatrin
Labeler cipla usa, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

vigabatrin 500 mg/mL

Manufacturer
Cipla USA, Inc.

Identifiers & Regulatory

Product NDC 69097-964
Product ID 69097-964_4cdad60f-7614-47cb-8594-3c0257e55c28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211592
Listing Expiration 2026-12-31
Marketing Start 2019-12-04

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097964
Hyphenated Format 69097-964

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 ANDA211592 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/mL
source: ndc
Packaging
  • 50 PACKET in 1 CARTON (69097-964-53) / 10 mL in 1 PACKET
source: ndc

Packages (1)

69097-964-53 50 PACKET in 1 CARTON (69097-964-53) / 10 mL in 1 PACKET

Ingredients (1)

vigabatrin (500 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": "4cdad60f-7614-47cb-8594-3c0257e55c28", "openfda": {"nui": ["N0000175753"], "unii": ["GR120KRT6K"], "rxcui": ["250820"], "spl_set_id": ["823cc915-0350-4780-85ed-cd1c338e429d"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Cipla USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (69097-964-53)  / 10 mL in 1 PACKET", "package_ndc": "69097-964-53", "marketing_start_date": "20191204"}], "brand_name": "VIGABATRIN", "product_id": "69097-964_4cdad60f-7614-47cb-8594-3c0257e55c28", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "69097-964", "generic_name": "vigabatrin", "labeler_name": "Cipla USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIGABATRIN", "active_ingredients": [{"name": "VIGABATRIN", "strength": "500 mg/mL"}], "application_number": "ANDA211592", "marketing_category": "ANDA", "marketing_start_date": "20191204", "listing_expiration_date": "20261231"}