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 SOLUTION
Routes
ORAL
Active Ingredients

gabapentin 250 mg/5mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-698
Product ID 65162-698_bcc054b1-a2fa-40b7-b150-b937763fcf7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202024
Listing Expiration 2026-12-31
Marketing Start 2011-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162698
Hyphenated Format 65162-698

Supplemental Identifiers

RxCUI
283523
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 ANDA202024 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 50 CUP, UNIT-DOSE in 1 CARTON (65162-698-54) / 5 mL in 1 CUP, UNIT-DOSE (65162-698-39)
  • 473 mL in 1 BOTTLE (65162-698-90)
source: ndc

Packages (2)

65162-698-54 50 CUP, UNIT-DOSE in 1 CARTON (65162-698-54) / 5 mL in 1 CUP, UNIT-DOSE (65162-698-39) 65162-698-90 473 mL in 1 BOTTLE (65162-698-90)

Ingredients (1)

gabapentin (250 mg/5mL)

Linked Drug Pages (1)

Gabapentin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bcc054b1-a2fa-40b7-b150-b937763fcf7f", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["283523"], "spl_set_id": ["772d9e7a-3811-455a-99e6-f2a3d0769b9b"], "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": "50 CUP, UNIT-DOSE in 1 CARTON (65162-698-54)  / 5 mL in 1 CUP, UNIT-DOSE (65162-698-39)", "package_ndc": "65162-698-54", "marketing_start_date": "20110930"}, {"sample": false, "description": "473 mL in 1 BOTTLE (65162-698-90)", "package_ndc": "65162-698-90", "marketing_start_date": "20110930"}], "brand_name": "Gabapentin", "product_id": "65162-698_bcc054b1-a2fa-40b7-b150-b937763fcf7f", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "65162-698", "generic_name": "Gabapentin", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "250 mg/5mL"}], "application_number": "ANDA202024", "marketing_category": "ANDA", "marketing_start_date": "20110930", "listing_expiration_date": "20261231"}