vigabatrin for oral solution

Generic: vigabatrin

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigabatrin for oral solution
Generic Name vigabatrin
Labeler camber pharmaceuticals, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

vigabatrin 50 mg/mL

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-009
Product ID 31722-009_16ae8082-260c-b789-e063-6294a90ab6e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213519
Listing Expiration 2026-12-31
Marketing Start 2021-01-26

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722009
Hyphenated Format 31722-009

Supplemental Identifiers

RxCUI
250820
UPC
0331722009508
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 for oral solution (source: ndc)
Generic Name vigabatrin (source: ndc)
Application Number ANDA213519 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 50 PACKET in 1 CARTON (31722-009-50) / 10 mL in 1 PACKET
source: ndc

Packages (1)

31722-009-50 50 PACKET in 1 CARTON (31722-009-50) / 10 mL in 1 PACKET

Ingredients (1)

vigabatrin (50 mg/mL)

Linked Drug Pages (1)

vigabatrin for oral solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "16ae8082-260c-b789-e063-6294a90ab6e8", "openfda": {"nui": ["N0000175753"], "upc": ["0331722009508"], "unii": ["GR120KRT6K"], "rxcui": ["250820"], "spl_set_id": ["bda491b6-47ba-400b-9816-b6d15c6e2683"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (31722-009-50)  / 10 mL in 1 PACKET", "package_ndc": "31722-009-50", "marketing_start_date": "20210126"}], "brand_name": "vigabatrin for oral solution", "product_id": "31722-009_16ae8082-260c-b789-e063-6294a90ab6e8", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "31722-009", "generic_name": "vigabatrin", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "vigabatrin for oral solution", "active_ingredients": [{"name": "VIGABATRIN", "strength": "50 mg/mL"}], "application_number": "ANDA213519", "marketing_category": "ANDA", "marketing_start_date": "20210126", "listing_expiration_date": "20261231"}