gabapentin

Generic: gabapentin

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

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler sciegen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gabapentin 600 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-524
Product ID 50228-524_3f2e32c6-5993-0189-e063-6294a90a0ff6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218491
Listing Expiration 2026-12-31
Marketing Start 2025-09-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228524
Hyphenated Format 50228-524

Supplemental Identifiers

RxCUI
1806380 1806382
UPC
0350228523905
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 ANDA218491 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (50228-524-05)
  • 30 TABLET in 1 BOTTLE (50228-524-30)
  • 90 TABLET in 1 BOTTLE (50228-524-90)
source: ndc

Packages (3)

50228-524-05 500 TABLET in 1 BOTTLE (50228-524-05) 50228-524-30 30 TABLET in 1 BOTTLE (50228-524-30) 50228-524-90 90 TABLET in 1 BOTTLE (50228-524-90)

Ingredients (1)

gabapentin (600 mg/1)

Linked Drug Pages (1)

gabapentin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f2e32c6-5993-0189-e063-6294a90a0ff6", "openfda": {"nui": ["N0000008486"], "upc": ["0350228523905"], "unii": ["6CW7F3G59X"], "rxcui": ["1806380", "1806382"], "spl_set_id": ["3f2e3ac5-5233-fd57-e063-6294a90a849e"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (50228-524-05)", "package_ndc": "50228-524-05", "marketing_start_date": "20250920"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50228-524-30)", "package_ndc": "50228-524-30", "marketing_start_date": "20250920"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50228-524-90)", "package_ndc": "50228-524-90", "marketing_start_date": "20250920"}], "brand_name": "gabapentin", "product_id": "50228-524_3f2e32c6-5993-0189-e063-6294a90a0ff6", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50228-524", "generic_name": "gabapentin", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "600 mg/1"}], "application_number": "ANDA218491", "marketing_category": "ANDA", "marketing_start_date": "20250920", "listing_expiration_date": "20261231"}