gabapentin

Generic: gabapentin

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gabapentin 800 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-426
Product ID 71610-426_f44af22b-a99e-4c28-94af-f260bbb6ba0f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203244
Listing Expiration 2026-12-31
Marketing Start 2014-01-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610426
Hyphenated Format 71610-426

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 ANDA203244 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-426-60)
source: ndc

Packages (1)

71610-426-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-426-60)

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": "f44af22b-a99e-4c28-94af-f260bbb6ba0f", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310434"], "spl_set_id": ["ba2a8352-5776-4edb-914e-ce1d18ccda32"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-426-60)", "package_ndc": "71610-426-60", "marketing_start_date": "20200515"}], "brand_name": "Gabapentin", "product_id": "71610-426_f44af22b-a99e-4c28-94af-f260bbb6ba0f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-426", "generic_name": "GABAPENTIN", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA203244", "marketing_category": "ANDA", "marketing_start_date": "20140111", "listing_expiration_date": "20261231"}