gabapentin

Generic: gabapentin

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler epic pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-656
Product ID 42806-656_c48c3c6d-4407-4312-8e81-46db64698cb7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216252
Listing Expiration 2026-12-31
Marketing Start 2024-02-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806656
Hyphenated Format 42806-656

Supplemental Identifiers

RxCUI
1806380 1806382
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 ANDA216252 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (42806-656-09)
source: ndc

Packages (1)

42806-656-09 90 TABLET in 1 BOTTLE (42806-656-09)

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": "c48c3c6d-4407-4312-8e81-46db64698cb7", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["1806380", "1806382"], "spl_set_id": ["d592d828-8df1-480d-b179-bb9260a9c824"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (42806-656-09)", "package_ndc": "42806-656-09", "marketing_start_date": "20240226"}], "brand_name": "Gabapentin", "product_id": "42806-656_c48c3c6d-4407-4312-8e81-46db64698cb7", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "42806-656", "generic_name": "Gabapentin", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "ANDA216252", "marketing_category": "ANDA", "marketing_start_date": "20240226", "listing_expiration_date": "20261231"}