vigabatrin

Generic: vigabatrin

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

Drug Facts

Product Profile

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

vigabatrin 50 mg/mL

Manufacturer
ENDO USA, Inc.

Identifiers & Regulatory

Product NDC 49884-358
Product ID 49884-358_85f80498-dbd9-46e7-bac8-72db25a0ef22
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208218
Listing Expiration 2026-12-31
Marketing Start 2017-04-27

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884358
Hyphenated Format 49884-358

Supplemental Identifiers

RxCUI
250820
UPC
0349884358037 0349884358525
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 ANDA208218 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 50 PACKET in 1 CARTON (49884-358-03) / 10 mL in 1 PACKET (49884-358-52)
source: ndc

Packages (1)

49884-358-03 50 PACKET in 1 CARTON (49884-358-03) / 10 mL in 1 PACKET (49884-358-52)

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": "85f80498-dbd9-46e7-bac8-72db25a0ef22", "openfda": {"nui": ["N0000175753"], "upc": ["0349884358037", "0349884358525"], "unii": ["GR120KRT6K"], "rxcui": ["250820"], "spl_set_id": ["e7cbc0a5-8c28-4451-9176-b608e228ba66"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["ENDO USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (49884-358-03)  / 10 mL in 1 PACKET (49884-358-52)", "package_ndc": "49884-358-03", "marketing_start_date": "20170427"}], "brand_name": "VIGABATRIN", "product_id": "49884-358_85f80498-dbd9-46e7-bac8-72db25a0ef22", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "49884-358", "generic_name": "vigabatrin", "labeler_name": "ENDO USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIGABATRIN", "active_ingredients": [{"name": "VIGABATRIN", "strength": "50 mg/mL"}], "application_number": "ANDA208218", "marketing_category": "ANDA", "marketing_start_date": "20170427", "listing_expiration_date": "20261231"}