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 71610-737
Product ID 71610-737_9f352e62-f8a6-4b97-9d27-a147a3439f71
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205101
Listing Expiration 2026-12-31
Marketing Start 2016-02-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610737
Hyphenated Format 71610-737

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
  • 30 TABLET in 1 BOTTLE (71610-737-30)
  • 45 TABLET in 1 BOTTLE (71610-737-45)
  • 60 TABLET in 1 BOTTLE (71610-737-53)
  • 90 TABLET in 1 BOTTLE (71610-737-60)
  • 120 TABLET in 1 BOTTLE (71610-737-70)
  • 135 TABLET in 1 BOTTLE (71610-737-73)
  • 180 TABLET in 1 BOTTLE (71610-737-80)
  • 270 TABLET in 1 BOTTLE (71610-737-92)
source: ndc

Packages (8)

71610-737-30 30 TABLET in 1 BOTTLE (71610-737-30) 71610-737-45 45 TABLET in 1 BOTTLE (71610-737-45) 71610-737-53 60 TABLET in 1 BOTTLE (71610-737-53) 71610-737-60 90 TABLET in 1 BOTTLE (71610-737-60) 71610-737-70 120 TABLET in 1 BOTTLE (71610-737-70) 71610-737-73 135 TABLET in 1 BOTTLE (71610-737-73) 71610-737-80 180 TABLET in 1 BOTTLE (71610-737-80) 71610-737-92 270 TABLET in 1 BOTTLE (71610-737-92)

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": "9f352e62-f8a6-4b97-9d27-a147a3439f71", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310434"], "spl_set_id": ["af62bb7e-162e-4e2a-8eb0-d50f66678707"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-737-30)", "package_ndc": "71610-737-30", "marketing_start_date": "20230922"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-737-45)", "package_ndc": "71610-737-45", "marketing_start_date": "20230922"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-737-53)", "package_ndc": "71610-737-53", "marketing_start_date": "20230922"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-737-60)", "package_ndc": "71610-737-60", "marketing_start_date": "20230922"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-737-70)", "package_ndc": "71610-737-70", "marketing_start_date": "20230922"}, {"sample": false, "description": "135 TABLET in 1 BOTTLE (71610-737-73)", "package_ndc": "71610-737-73", "marketing_start_date": "20230922"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-737-80)", "package_ndc": "71610-737-80", "marketing_start_date": "20230922"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (71610-737-92)", "package_ndc": "71610-737-92", "marketing_start_date": "20230922"}], "brand_name": "Gabapentin", "product_id": "71610-737_9f352e62-f8a6-4b97-9d27-a147a3439f71", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-737", "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": "20160204", "listing_expiration_date": "20261231"}