gabapentin

Generic: gabapentin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gabapentin 600 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-523
Product ID 65862-523_700d09f5-99cc-492d-ab49-442f674d9c5d
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 65862523
Hyphenated Format 65862-523

Supplemental Identifiers

RxCUI
310433 310434
UPC
0365862524010 0365862523013
UNII
6CW7F3G59X
NUI
N0000008486

Packaging Origin

Original Packager
true

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
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-523-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-523-05)
  • 2500 TABLET, FILM COATED in 1 BOTTLE (65862-523-26)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-523-90)
source: ndc

Packages (4)

65862-523-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-523-01) 65862-523-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-523-05) 65862-523-26 2500 TABLET, FILM COATED in 1 BOTTLE (65862-523-26) 65862-523-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-523-90)

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": "700d09f5-99cc-492d-ab49-442f674d9c5d", "openfda": {"nui": ["N0000008486"], "upc": ["0365862524010", "0365862523013"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["25cf6c40-a239-4dd0-9cad-28da84d285db"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-523-01)", "package_ndc": "65862-523-01", "marketing_start_date": "20111006"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-523-05)", "package_ndc": "65862-523-05", "marketing_start_date": "20111006"}, {"sample": false, "description": "2500 TABLET, FILM COATED in 1 BOTTLE (65862-523-26)", "package_ndc": "65862-523-26", "marketing_start_date": "20111006"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-523-90)", "package_ndc": "65862-523-90", "marketing_start_date": "20111006"}], "brand_name": "Gabapentin", "product_id": "65862-523_700d09f5-99cc-492d-ab49-442f674d9c5d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "65862-523", "generic_name": "Gabapentin", "labeler_name": "Aurobindo Pharma Limited", "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"}