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 CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
Exelan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76282-627
Product ID 76282-627_5e0a57d7-9068-43d3-be26-96f646720fde
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090705
Listing Expiration 2026-12-31
Marketing Start 2018-09-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282627
Hyphenated Format 76282-627

Supplemental Identifiers

RxCUI
310430 310431 310432
UPC
0376282323909 0376282627182 0376282323053 0376282321189 0376282627304 0376282627908 0376282627601 0376282323275 0376282321271 0376282321059 0376282321905 0376282323015 0376282321011 0376282627274 0376282627014
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 ANDA090705 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (76282-627-01)
  • 500 CAPSULE in 1 BOTTLE (76282-627-05)
  • 180 CAPSULE in 1 BOTTLE (76282-627-18)
  • 270 CAPSULE in 1 BOTTLE (76282-627-27)
  • 30 CAPSULE in 1 BOTTLE (76282-627-30)
  • 60 CAPSULE in 1 BOTTLE (76282-627-60)
  • 90 CAPSULE in 1 BOTTLE (76282-627-90)
source: ndc

Packages (7)

76282-627-01 100 CAPSULE in 1 BOTTLE (76282-627-01) 76282-627-05 500 CAPSULE in 1 BOTTLE (76282-627-05) 76282-627-18 180 CAPSULE in 1 BOTTLE (76282-627-18) 76282-627-27 270 CAPSULE in 1 BOTTLE (76282-627-27) 76282-627-30 30 CAPSULE in 1 BOTTLE (76282-627-30) 76282-627-60 60 CAPSULE in 1 BOTTLE (76282-627-60) 76282-627-90 90 CAPSULE in 1 BOTTLE (76282-627-90)

Ingredients (1)

gabapentin (300 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": "5e0a57d7-9068-43d3-be26-96f646720fde", "openfda": {"nui": ["N0000008486"], "upc": ["0376282323909", "0376282627182", "0376282323053", "0376282321189", "0376282627304", "0376282627908", "0376282627601", "0376282323275", "0376282321271", "0376282321059", "0376282321905", "0376282323015", "0376282321011", "0376282627274", "0376282627014"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432"], "spl_set_id": ["41d1ead3-046e-4abf-ae0a-cb126a1f5848"], "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 CAPSULE in 1 BOTTLE (76282-627-01)", "package_ndc": "76282-627-01", "marketing_start_date": "20180913"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (76282-627-05)", "package_ndc": "76282-627-05", "marketing_start_date": "20180913"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (76282-627-18)", "package_ndc": "76282-627-18", "marketing_start_date": "20180913"}, {"sample": false, "description": "270 CAPSULE in 1 BOTTLE (76282-627-27)", "package_ndc": "76282-627-27", "marketing_start_date": "20180913"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76282-627-30)", "package_ndc": "76282-627-30", "marketing_start_date": "20180913"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76282-627-60)", "package_ndc": "76282-627-60", "marketing_start_date": "20180913"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76282-627-90)", "package_ndc": "76282-627-90", "marketing_start_date": "20180913"}], "brand_name": "GABAPENTIN", "product_id": "76282-627_5e0a57d7-9068-43d3-be26-96f646720fde", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "76282-627", "generic_name": "GABAPENTIN", "labeler_name": "Exelan Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GABAPENTIN", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "ANDA090705", "marketing_category": "ANDA", "marketing_start_date": "20180913", "listing_expiration_date": "20261231"}