gabapentin

Generic: gabapentin

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

Drug Facts

Product Profile

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

gabapentin 800 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8688
Product ID 68788-8688_c5b2bddf-74f7-48c8-b6ab-1cfc05dab3f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203244
Listing Expiration 2026-12-31
Marketing Start 2024-06-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888688
Hyphenated Format 68788-8688

Supplemental Identifiers

RxCUI
310433 310434
UNII
6CW7F3G59X
NUI
N0000008486

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 ANDA203244 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8688-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8688-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8688-6)
  • 120 TABLET, FILM COATED in 1 BOTTLE (68788-8688-8)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8688-9)
source: ndc

Packages (5)

68788-8688-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8688-1) 68788-8688-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8688-3) 68788-8688-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8688-6) 68788-8688-8 120 TABLET, FILM COATED in 1 BOTTLE (68788-8688-8) 68788-8688-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8688-9)

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": "c5b2bddf-74f7-48c8-b6ab-1cfc05dab3f5", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["156fe804-d674-4b52-82f5-6cd7715c707b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8688-1)", "package_ndc": "68788-8688-1", "marketing_start_date": "20240605"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8688-3)", "package_ndc": "68788-8688-3", "marketing_start_date": "20240605"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8688-6)", "package_ndc": "68788-8688-6", "marketing_start_date": "20240605"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (68788-8688-8)", "package_ndc": "68788-8688-8", "marketing_start_date": "20240605"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8688-9)", "package_ndc": "68788-8688-9", "marketing_start_date": "20240605"}], "brand_name": "Gabapentin", "product_id": "68788-8688_c5b2bddf-74f7-48c8-b6ab-1cfc05dab3f5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68788-8688", "generic_name": "GABAPENTIN", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA203244", "marketing_category": "ANDA", "marketing_start_date": "20240605", "listing_expiration_date": "20261231"}