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
Routes
ORAL
Active Ingredients

gabapentin 800 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-778
Product ID 71610-778_2e79999c-5c38-42c2-bd3a-91286ab18ed5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205101
Listing Expiration 2026-12-31
Marketing Start 2023-11-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610778
Hyphenated Format 71610-778

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 ANDA205101 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 45 TABLET in 1 BOTTLE (71610-778-45)
  • 60 TABLET in 1 BOTTLE (71610-778-53)
  • 120 TABLET in 1 BOTTLE (71610-778-70)
  • 270 TABLET in 1 BOTTLE (71610-778-92)
source: ndc

Packages (4)

71610-778-45 45 TABLET in 1 BOTTLE (71610-778-45) 71610-778-53 60 TABLET in 1 BOTTLE (71610-778-53) 71610-778-70 120 TABLET in 1 BOTTLE (71610-778-70) 71610-778-92 270 TABLET in 1 BOTTLE (71610-778-92)

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": "2e79999c-5c38-42c2-bd3a-91286ab18ed5", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310434"], "spl_set_id": ["79cd9dea-e7d0-44db-afba-964cb99f32b6"], "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 in 1 BOTTLE (71610-778-45)", "package_ndc": "71610-778-45", "marketing_start_date": "20240125"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-778-53)", "package_ndc": "71610-778-53", "marketing_start_date": "20240131"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-778-70)", "package_ndc": "71610-778-70", "marketing_start_date": "20240125"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (71610-778-92)", "package_ndc": "71610-778-92", "marketing_start_date": "20240125"}], "brand_name": "Gabapentin", "product_id": "71610-778_2e79999c-5c38-42c2-bd3a-91286ab18ed5", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-778", "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": "ANDA205101", "marketing_category": "ANDA", "marketing_start_date": "20231103", "listing_expiration_date": "20261231"}