gabapentin

Generic: gabapentin

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-102
Product ID 65162-102_0a962d55-bd53-462f-b9a0-0bbb6930c93e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078428
Listing Expiration 2026-12-31
Marketing Start 2009-11-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162102
Hyphenated Format 65162-102

Supplemental Identifiers

RxCUI
310430 310431 310432
UPC
0365162101034 0365162102031 0365162103038
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 ANDA078428 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (65162-102-03)
  • 100 CAPSULE in 1 BOTTLE (65162-102-10)
  • 1000 CAPSULE in 1 BOTTLE (65162-102-11)
  • 500 CAPSULE in 1 BOTTLE (65162-102-50)
source: ndc

Packages (4)

65162-102-03 30 CAPSULE in 1 BOTTLE (65162-102-03) 65162-102-10 100 CAPSULE in 1 BOTTLE (65162-102-10) 65162-102-11 1000 CAPSULE in 1 BOTTLE (65162-102-11) 65162-102-50 500 CAPSULE in 1 BOTTLE (65162-102-50)

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": "0a962d55-bd53-462f-b9a0-0bbb6930c93e", "openfda": {"nui": ["N0000008486"], "upc": ["0365162101034", "0365162102031", "0365162103038"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432"], "spl_set_id": ["507bf6d0-e7a2-413d-9848-cd2445a1411d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (65162-102-03)", "package_ndc": "65162-102-03", "marketing_start_date": "20091124"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (65162-102-10)", "package_ndc": "65162-102-10", "marketing_start_date": "20091124"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (65162-102-11)", "package_ndc": "65162-102-11", "marketing_start_date": "20091124"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (65162-102-50)", "package_ndc": "65162-102-50", "marketing_start_date": "20091124"}], "brand_name": "Gabapentin", "product_id": "65162-102_0a962d55-bd53-462f-b9a0-0bbb6930c93e", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "65162-102", "generic_name": "Gabapentin", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "ANDA078428", "marketing_category": "ANDA", "marketing_start_date": "20091124", "listing_expiration_date": "20261231"}