gabapentin

Generic: gabapentin

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler avpak
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

gabapentin 800 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-326
Product ID 50268-326_2b48eef3-a050-7828-e063-6294a90a4a83
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207057
Listing Expiration 2026-12-31
Marketing Start 2023-08-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268326
Hyphenated Format 50268-326

Supplemental Identifiers

RxCUI
310434
UNII
6CW7F3G59X
NUI
N0000008486

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 ANDA207057 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX (50268-326-13) / 1 TABLET, COATED in 1 BLISTER PACK (50268-326-11)
source: ndc

Packages (1)

50268-326-13 30 BLISTER PACK in 1 BOX (50268-326-13) / 1 TABLET, COATED in 1 BLISTER PACK (50268-326-11)

Ingredients (1)

gabapentin (800 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": "2b48eef3-a050-7828-e063-6294a90a4a83", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310434"], "spl_set_id": ["026a7219-78ba-48c7-e063-6394a90ad736"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX (50268-326-13)  / 1 TABLET, COATED in 1 BLISTER PACK (50268-326-11)", "package_ndc": "50268-326-13", "marketing_start_date": "20230808"}], "brand_name": "Gabapentin", "product_id": "50268-326_2b48eef3-a050-7828-e063-6294a90a4a83", "dosage_form": "TABLET, COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50268-326", "generic_name": "Gabapentin", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA207057", "marketing_category": "ANDA", "marketing_start_date": "20230808", "listing_expiration_date": "20261231"}