gabapentin

Generic: gabapentin

Labeler: ajenat pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler ajenat pharmaceuticals llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

gabapentin 250 mg/5mL

Manufacturer
Ajenat Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 82983-423
Product ID 82983-423_1e85899c-edf0-49d0-a007-06f8e6655a43
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 82983423
Hyphenated Format 82983-423

Supplemental Identifiers

RxCUI
283523
UPC
0382983423473
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 (82983-423-47)
source: ndc

Packages (1)

82983-423-47 473 mL in 1 BOTTLE (82983-423-47)

Ingredients (1)

gabapentin (250 mg/5mL)

Linked Drug Pages (1)

Gabapentin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1e85899c-edf0-49d0-a007-06f8e6655a43", "openfda": {"nui": ["N0000008486"], "upc": ["0382983423473"], "unii": ["6CW7F3G59X"], "rxcui": ["283523"], "spl_set_id": ["02304deb-7b4a-452f-9b1a-64ca0aedbcc2"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Ajenat Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (82983-423-47)", "package_ndc": "82983-423-47", "marketing_start_date": "20250806"}], "brand_name": "Gabapentin", "product_id": "82983-423_1e85899c-edf0-49d0-a007-06f8e6655a43", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "82983-423", "generic_name": "Gabapentin", "labeler_name": "Ajenat Pharmaceuticals LLC", "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"}