vigabatrin

Generic: vigabatrin

Labeler: dr. reddys laboratories inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigabatrin
Generic Name vigabatrin
Labeler dr. reddys laboratories inc.,
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

vigabatrin 50 mg/mL

Manufacturer
Dr. Reddys Laboratories Inc.,

Identifiers & Regulatory

Product NDC 43598-697
Product ID 43598-697_108f12cf-4bfc-4406-1d50-d57e656f6c8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211481
Listing Expiration 2026-12-31
Marketing Start 2018-11-21

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598697
Hyphenated Format 43598-697

Supplemental Identifiers

RxCUI
250820
UPC
0343598697505
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 ANDA211481 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 50 PACKET in 1 CARTON (43598-697-50) / 10 mL in 1 PACKET (43598-697-11)
source: ndc

Packages (1)

43598-697-50 50 PACKET in 1 CARTON (43598-697-50) / 10 mL in 1 PACKET (43598-697-11)

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": "108f12cf-4bfc-4406-1d50-d57e656f6c8c", "openfda": {"nui": ["N0000175753"], "upc": ["0343598697505"], "unii": ["GR120KRT6K"], "rxcui": ["250820"], "spl_set_id": ["f6be436e-46c7-e9ab-0fcf-e8d04dc12b72"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Dr. Reddys Laboratories Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (43598-697-50)  / 10 mL in 1 PACKET (43598-697-11)", "package_ndc": "43598-697-50", "marketing_start_date": "20181121"}], "brand_name": "Vigabatrin", "product_id": "43598-697_108f12cf-4bfc-4406-1d50-d57e656f6c8c", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "43598-697", "generic_name": "Vigabatrin", "labeler_name": "Dr. Reddys Laboratories Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vigabatrin", "active_ingredients": [{"name": "VIGABATRIN", "strength": "50 mg/mL"}], "application_number": "ANDA211481", "marketing_category": "ANDA", "marketing_start_date": "20181121", "listing_expiration_date": "20261231"}