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, COATED
Routes
ORAL
Active Ingredients

gabapentin 800 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0204
Product ID 80425-0204_2a99e9e8-3d19-ee0b-e063-6294a90ae4ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207057
Listing Expiration 2026-12-31
Marketing Start 2022-10-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250204
Hyphenated Format 80425-0204

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 ANDA207057 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (80425-0204-1)
  • 60 TABLET, COATED in 1 BOTTLE (80425-0204-2)
  • 90 TABLET, COATED in 1 BOTTLE (80425-0204-3)
  • 120 TABLET, COATED in 1 BOTTLE (80425-0204-4)
source: ndc

Packages (4)

80425-0204-1 30 TABLET, COATED in 1 BOTTLE (80425-0204-1) 80425-0204-2 60 TABLET, COATED in 1 BOTTLE (80425-0204-2) 80425-0204-3 90 TABLET, COATED in 1 BOTTLE (80425-0204-3) 80425-0204-4 120 TABLET, COATED in 1 BOTTLE (80425-0204-4)

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": "2a99e9e8-3d19-ee0b-e063-6294a90ae4ef", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["ec1a01fe-5531-21df-e053-2a95a90a0561"], "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, COATED in 1 BOTTLE (80425-0204-1)", "package_ndc": "80425-0204-1", "marketing_start_date": "20231101"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (80425-0204-2)", "package_ndc": "80425-0204-2", "marketing_start_date": "20231101"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (80425-0204-3)", "package_ndc": "80425-0204-3", "marketing_start_date": "20231101"}, {"sample": false, "description": "120 TABLET, COATED in 1 BOTTLE (80425-0204-4)", "package_ndc": "80425-0204-4", "marketing_start_date": "20231101"}], "brand_name": "Gabapentin", "product_id": "80425-0204_2a99e9e8-3d19-ee0b-e063-6294a90ae4ef", "dosage_form": "TABLET, COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "80425-0204", "generic_name": "Gabapentin", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA207057", "marketing_category": "ANDA", "marketing_start_date": "20221028", "listing_expiration_date": "20261231"}