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 CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 400 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-181
Product ID 50228-181_14e738dd-c304-44bc-b56e-ce7e27e8b153
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204989
Listing Expiration 2027-12-31
Marketing Start 2016-02-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228181
Hyphenated Format 50228-181

Supplemental Identifiers

RxCUI
310430 310431 310432
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 ANDA204989 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-01)
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-05)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-30)
source: ndc

Packages (3)

50228-181-01 100 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-01) 50228-181-05 500 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-05) 50228-181-30 30 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-30)

Ingredients (1)

gabapentin (400 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": "14e738dd-c304-44bc-b56e-ce7e27e8b153", "openfda": {"nui": ["N0000008486"], "upc": ["0350228180108", "0350228180054", "0350228181013", "0350228178013", "0350228181051", "0350228179010", "0350228180016", "0350228177016", "0350228179102", "0350228178051", "0350228177054"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432"], "spl_set_id": ["16542ee6-0e0e-4d3c-8b32-60ff6ef48846"], "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 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-01)", "package_ndc": "50228-181-01", "marketing_start_date": "20180820"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-05)", "package_ndc": "50228-181-05", "marketing_start_date": "20160218"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-30)", "package_ndc": "50228-181-30", "marketing_start_date": "20160218"}], "brand_name": "Gabapentin", "product_id": "50228-181_14e738dd-c304-44bc-b56e-ce7e27e8b153", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50228-181", "generic_name": "Gabapentin", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "400 mg/1"}], "application_number": "ANDA204989", "marketing_category": "ANDA", "marketing_start_date": "20160218", "listing_expiration_date": "20271231"}