gabapentin

Generic: gabapentin

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gabapentin 600 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0097
Product ID 80425-0097_2a998d83-7bad-3f5e-e063-6294a90acd3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200651
Listing Expiration 2026-12-31
Marketing Start 2011-10-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250097
Hyphenated Format 80425-0097

Supplemental Identifiers

RxCUI
310433
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 ANDA200651 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0097-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0097-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0097-3)
  • 120 TABLET, FILM COATED in 1 BOTTLE (80425-0097-4)
source: ndc

Packages (4)

80425-0097-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0097-1) 80425-0097-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0097-2) 80425-0097-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0097-3) 80425-0097-4 120 TABLET, FILM COATED in 1 BOTTLE (80425-0097-4)

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": "2a998d83-7bad-3f5e-e063-6294a90acd3d", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433"], "spl_set_id": ["b37b1dcc-c7e9-8845-e053-2995a90a089e"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0097-1)", "package_ndc": "80425-0097-1", "marketing_start_date": "20111006"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0097-2)", "package_ndc": "80425-0097-2", "marketing_start_date": "20111006"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0097-3)", "package_ndc": "80425-0097-3", "marketing_start_date": "20111006"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (80425-0097-4)", "package_ndc": "80425-0097-4", "marketing_start_date": "20111006"}], "brand_name": "Gabapentin", "product_id": "80425-0097_2a998d83-7bad-3f5e-e063-6294a90acd3d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "80425-0097", "generic_name": "Gabapentin", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "600 mg/1"}], "application_number": "ANDA200651", "marketing_category": "ANDA", "marketing_start_date": "20111006", "listing_expiration_date": "20261231"}