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 800 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-178
Product ID 50228-178_162342b0-5fbd-4fe4-be73-9c9c34736b4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205101
Listing Expiration 2027-12-31
Marketing Start 2016-02-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228178
Hyphenated Format 50228-178

Supplemental Identifiers

RxCUI
310433 310434
UPC
0350228180108 0350228180054 0350228181013 0350228178013 0350228181051 0350228179010 0350228180016 0350228177016 0350228179102 0350228178051 0350228177054
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 ANDA205101 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (50228-178-01)
  • 500 TABLET in 1 BOTTLE (50228-178-05)
  • 30 TABLET in 1 BOTTLE (50228-178-30)
source: ndc

Packages (3)

50228-178-01 100 TABLET in 1 BOTTLE (50228-178-01) 50228-178-05 500 TABLET in 1 BOTTLE (50228-178-05) 50228-178-30 30 TABLET in 1 BOTTLE (50228-178-30)

Ingredients (1)

gabapentin (800 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": "162342b0-5fbd-4fe4-be73-9c9c34736b4c", "openfda": {"nui": ["N0000008486"], "upc": ["0350228180108", "0350228180054", "0350228181013", "0350228178013", "0350228181051", "0350228179010", "0350228180016", "0350228177016", "0350228179102", "0350228178051", "0350228177054"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["5ab9c18b-9568-4dcb-90b0-252aef8f8dc2"], "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": "100 TABLET in 1 BOTTLE (50228-178-01)", "package_ndc": "50228-178-01", "marketing_start_date": "20180820"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (50228-178-05)", "package_ndc": "50228-178-05", "marketing_start_date": "20160204"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50228-178-30)", "package_ndc": "50228-178-30", "marketing_start_date": "20160204"}], "brand_name": "Gabapentin", "product_id": "50228-178_162342b0-5fbd-4fe4-be73-9c9c34736b4c", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50228-178", "generic_name": "Gabapentin", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA205101", "marketing_category": "ANDA", "marketing_start_date": "20160204", "listing_expiration_date": "20271231"}