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 600 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-069
Product ID 71610-069_cef6341b-bae4-4e08-a609-1afef9307f2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077525
Listing Expiration 2026-12-31
Marketing Start 2006-08-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610069
Hyphenated Format 71610-069

Supplemental Identifiers

RxCUI
310433
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 ANDA077525 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-069-45)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-069-60)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71610-069-80)
  • 270 TABLET, FILM COATED in 1 BOTTLE (71610-069-92)
source: ndc

Packages (4)

71610-069-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-069-45) 71610-069-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-069-60) 71610-069-80 180 TABLET, FILM COATED in 1 BOTTLE (71610-069-80) 71610-069-92 270 TABLET, FILM COATED in 1 BOTTLE (71610-069-92)

Ingredients (1)

gabapentin (600 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": "cef6341b-bae4-4e08-a609-1afef9307f2e", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433"], "spl_set_id": ["7790d906-af26-4e60-bc6f-e906ec03cc24"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-069-45)", "package_ndc": "71610-069-45", "marketing_start_date": "20210226"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-069-60)", "package_ndc": "71610-069-60", "marketing_start_date": "20180515"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71610-069-80)", "package_ndc": "71610-069-80", "marketing_start_date": "20180515"}, {"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (71610-069-92)", "package_ndc": "71610-069-92", "marketing_start_date": "20180515"}], "brand_name": "gabapentin", "product_id": "71610-069_cef6341b-bae4-4e08-a609-1afef9307f2e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-069", "generic_name": "gabapentin", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "600 mg/1"}], "application_number": "ANDA077525", "marketing_category": "ANDA", "marketing_start_date": "20060824", "listing_expiration_date": "20261231"}