gabapentin

Generic: gabapentin

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gabapentin 800 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-497
Product ID 76420-497_eaa81374-5d2c-60d1-e053-2a95a90af8ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205101
Listing Expiration 2026-12-31
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 76420497
Hyphenated Format 76420-497

Supplemental Identifiers

RxCUI
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 ANDA205101 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76420-497-01)
  • 500 TABLET in 1 BOTTLE (76420-497-05)
  • 120 TABLET in 1 BOTTLE (76420-497-12)
  • 240 TABLET in 1 BOTTLE (76420-497-24)
  • 30 TABLET in 1 BOTTLE (76420-497-30)
  • 60 TABLET in 1 BOTTLE (76420-497-60)
  • 90 TABLET in 1 BOTTLE (76420-497-90)
source: ndc

Packages (7)

76420-497-01 100 TABLET in 1 BOTTLE (76420-497-01) 76420-497-05 500 TABLET in 1 BOTTLE (76420-497-05) 76420-497-12 120 TABLET in 1 BOTTLE (76420-497-12) 76420-497-24 240 TABLET in 1 BOTTLE (76420-497-24) 76420-497-30 30 TABLET in 1 BOTTLE (76420-497-30) 76420-497-60 60 TABLET in 1 BOTTLE (76420-497-60) 76420-497-90 90 TABLET in 1 BOTTLE (76420-497-90)

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": "eaa81374-5d2c-60d1-e053-2a95a90af8ea", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310434"], "spl_set_id": ["9d544944-ea95-42e1-8c65-9e442437f0ee"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-497-01)", "package_ndc": "76420-497-01", "marketing_start_date": "20221010"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76420-497-05)", "package_ndc": "76420-497-05", "marketing_start_date": "20221010"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (76420-497-12)", "package_ndc": "76420-497-12", "marketing_start_date": "20221010"}, {"sample": false, "description": "240 TABLET in 1 BOTTLE (76420-497-24)", "package_ndc": "76420-497-24", "marketing_start_date": "20221010"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-497-30)", "package_ndc": "76420-497-30", "marketing_start_date": "20221010"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-497-60)", "package_ndc": "76420-497-60", "marketing_start_date": "20221010"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-497-90)", "package_ndc": "76420-497-90", "marketing_start_date": "20221010"}], "brand_name": "Gabapentin", "product_id": "76420-497_eaa81374-5d2c-60d1-e053-2a95a90af8ea", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "76420-497", "generic_name": "Gabapentin", "labeler_name": "Asclemed USA, 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": "20261231"}