vigabatrin

Generic: vigabatrin

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigabatrin
Generic Name vigabatrin
Labeler ascend laboratories, llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

vigabatrin 50 mg/mL

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-674
Product ID 67877-674_e55f8225-aa06-4e46-81d2-757233b95585
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213375
Listing Expiration 2026-12-31
Marketing Start 2020-12-03

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877674
Hyphenated Format 67877-674

Supplemental Identifiers

RxCUI
250820
UPC
0367877674636
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 ANDA213375 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 50 PACKET in 1 CARTON (67877-674-63) / 10 mL in 1 PACKET
source: ndc

Packages (1)

67877-674-63 50 PACKET in 1 CARTON (67877-674-63) / 10 mL in 1 PACKET

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": "e55f8225-aa06-4e46-81d2-757233b95585", "openfda": {"nui": ["N0000175753"], "upc": ["0367877674636"], "unii": ["GR120KRT6K"], "rxcui": ["250820"], "spl_set_id": ["ee835fb6-2b2b-40c4-b6d7-0ad0e790cda8"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (67877-674-63)  / 10 mL in 1 PACKET", "package_ndc": "67877-674-63", "marketing_start_date": "20201203"}], "brand_name": "VIGABATRIN", "product_id": "67877-674_e55f8225-aa06-4e46-81d2-757233b95585", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "67877-674", "generic_name": "VIGABATRIN", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIGABATRIN", "active_ingredients": [{"name": "VIGABATRIN", "strength": "50 mg/mL"}], "application_number": "ANDA213375", "marketing_category": "ANDA", "marketing_start_date": "20201203", "listing_expiration_date": "20261231"}