gabapentin

Generic: gabapentin

Labeler: kesin pharma corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler kesin pharma corporation
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

gabapentin 250 mg/5mL

Manufacturer
Kesin Pharma Corporation

Identifiers & Regulatory

Product NDC 81033-123
Product ID 81033-123_4470a571-3213-9849-e063-6394a90a39b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091286
Listing Expiration 2026-12-31
Marketing Start 2025-08-06

Pharmacologic Class

Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81033123
Hyphenated Format 81033-123

Supplemental Identifiers

RxCUI
283523
UPC
0381033123165
UNII
6CW7F3G59X
NUI
N0000008486

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 gabapentin (source: ndc)
Generic Name gabapentin (source: ndc)
Application Number ANDA091286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (81033-123-16)
source: ndc

Packages (1)

Ingredients (1)

gabapentin (250 mg/5mL)

Linked Drug Pages (2)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4470a571-3213-9849-e063-6394a90a39b2", "openfda": {"nui": ["N0000008486"], "upc": ["0381033123165"], "unii": ["6CW7F3G59X"], "rxcui": ["283523"], "spl_set_id": ["4470a567-93a6-a293-e063-6394a90affc1"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Kesin Pharma Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (81033-123-16)", "package_ndc": "81033-123-16", "marketing_start_date": "20250901"}], "brand_name": "Gabapentin", "product_id": "81033-123_4470a571-3213-9849-e063-6394a90a39b2", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "81033-123", "generic_name": "Gabapentin", "labeler_name": "Kesin Pharma Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "250 mg/5mL"}], "application_number": "ANDA091286", "marketing_category": "ANDA", "marketing_start_date": "20250806", "listing_expiration_date": "20261231"}