gabapentin

Generic: gabapentin

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler quality care products, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gabapentin 600 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-063
Product ID 83008-063_f29d6f9a-6f31-40d2-afed-56b35eeea612
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214957
Marketing Start 2024-06-10
Marketing End 2026-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83008063
Hyphenated Format 83008-063

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 ANDA214957 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (83008-063-60)
  • 90 TABLET in 1 BOTTLE (83008-063-90)
source: ndc

Packages (2)

83008-063-60 60 TABLET in 1 BOTTLE (83008-063-60) 83008-063-90 90 TABLET in 1 BOTTLE (83008-063-90)

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": "f29d6f9a-6f31-40d2-afed-56b35eeea612", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433"], "spl_set_id": ["10424d11-fca8-4825-8450-96d9a9190819"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (83008-063-60)", "package_ndc": "83008-063-60", "marketing_end_date": "20260630", "marketing_start_date": "20240610"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (83008-063-90)", "package_ndc": "83008-063-90", "marketing_end_date": "20260630", "marketing_start_date": "20240610"}], "brand_name": "GABAPENTIN", "product_id": "83008-063_f29d6f9a-6f31-40d2-afed-56b35eeea612", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "83008-063", "generic_name": "Gabapentin", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GABAPENTIN", "active_ingredients": [{"name": "GABAPENTIN", "strength": "600 mg/1"}], "application_number": "ANDA214957", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20240610"}