gabapentin

Generic: gabapentin

Labeler: exelan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler exelan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gabapentin 600 mg/1

Manufacturer
Exelan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 76282-405
Product ID 76282-405_20a38b18-352b-47a6-b640-091b42db10aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202764
Listing Expiration 2026-12-31
Marketing Start 2012-11-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282405
Hyphenated Format 76282-405

Supplemental Identifiers

RxCUI
310433 310434
UPC
0376282405902 0376282406909
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 ANDA202764 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76282-405-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (76282-405-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76282-405-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76282-405-90)
source: ndc

Packages (4)

76282-405-01 100 TABLET, FILM COATED in 1 BOTTLE (76282-405-01) 76282-405-05 500 TABLET, FILM COATED in 1 BOTTLE (76282-405-05) 76282-405-30 30 TABLET, FILM COATED in 1 BOTTLE (76282-405-30) 76282-405-90 90 TABLET, FILM COATED in 1 BOTTLE (76282-405-90)

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": "20a38b18-352b-47a6-b640-091b42db10aa", "openfda": {"nui": ["N0000008486"], "upc": ["0376282405902", "0376282406909"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["323dad14-ded9-4432-a265-c957e46cc6db"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Exelan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76282-405-01)", "package_ndc": "76282-405-01", "marketing_start_date": "20121102"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76282-405-05)", "package_ndc": "76282-405-05", "marketing_start_date": "20121102"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76282-405-30)", "package_ndc": "76282-405-30", "marketing_start_date": "20121102"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76282-405-90)", "package_ndc": "76282-405-90", "marketing_start_date": "20121102"}], "brand_name": "GABAPENTIN", "product_id": "76282-405_20a38b18-352b-47a6-b640-091b42db10aa", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "76282-405", "generic_name": "gabapentin", "labeler_name": "Exelan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GABAPENTIN", "active_ingredients": [{"name": "GABAPENTIN", "strength": "600 mg/1"}], "application_number": "ANDA202764", "marketing_category": "ANDA", "marketing_start_date": "20121102", "listing_expiration_date": "20261231"}