gabapentin

Generic: gabapentin

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gabapentin 800 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7108
Product ID 0904-7108_3e587d00-7f5f-42dc-b941-9796ee032327
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200651
Listing Expiration 2026-12-31
Marketing Start 2011-10-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047108
Hyphenated Format 0904-7108

Supplemental Identifiers

RxCUI
310433 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 ANDA200651 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7108-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7108-61 100 BLISTER PACK in 1 CARTON (0904-7108-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "3e587d00-7f5f-42dc-b941-9796ee032327", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["152adf1d-ec0c-4561-bf80-e4c7da158723"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7108-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7108-61", "marketing_start_date": "20111006"}], "brand_name": "Gabapentin", "product_id": "0904-7108_3e587d00-7f5f-42dc-b941-9796ee032327", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0904-7108", "generic_name": "Gabapentin", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA200651", "marketing_category": "ANDA", "marketing_start_date": "20111006", "listing_expiration_date": "20261231"}