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 600 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-621
Product ID 71610-621_bc931d95-28ae-405b-ad93-e1fe0b51eab9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214957
Listing Expiration 2026-12-31
Marketing Start 2021-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610621
Hyphenated Format 71610-621

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 ANDA214957 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (71610-621-15)
  • 30 TABLET in 1 BOTTLE (71610-621-30)
  • 45 TABLET in 1 BOTTLE (71610-621-45)
  • 60 TABLET in 1 BOTTLE (71610-621-53)
  • 90 TABLET in 1 BOTTLE (71610-621-60)
  • 120 TABLET in 1 BOTTLE (71610-621-70)
  • 135 TABLET in 1 BOTTLE (71610-621-73)
  • 180 TABLET in 1 BOTTLE (71610-621-80)
  • 270 TABLET in 1 BOTTLE (71610-621-92)
  • 360 TABLET in 1 BOTTLE (71610-621-94)
source: ndc

Packages (10)

71610-621-15 15 TABLET in 1 BOTTLE (71610-621-15) 71610-621-30 30 TABLET in 1 BOTTLE (71610-621-30) 71610-621-45 45 TABLET in 1 BOTTLE (71610-621-45) 71610-621-53 60 TABLET in 1 BOTTLE (71610-621-53) 71610-621-60 90 TABLET in 1 BOTTLE (71610-621-60) 71610-621-70 120 TABLET in 1 BOTTLE (71610-621-70) 71610-621-73 135 TABLET in 1 BOTTLE (71610-621-73) 71610-621-80 180 TABLET in 1 BOTTLE (71610-621-80) 71610-621-92 270 TABLET in 1 BOTTLE (71610-621-92) 71610-621-94 360 TABLET in 1 BOTTLE (71610-621-94)

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": "bc931d95-28ae-405b-ad93-e1fe0b51eab9", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433"], "spl_set_id": ["7f579665-afb7-4227-98c1-2eafee650504"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-621-15)", "package_ndc": "71610-621-15", "marketing_start_date": "20220124"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-621-30)", "package_ndc": "71610-621-30", "marketing_start_date": "20211202"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-621-45)", "package_ndc": "71610-621-45", "marketing_start_date": "20211202"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-621-53)", "package_ndc": "71610-621-53", "marketing_start_date": "20220124"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-621-60)", "package_ndc": "71610-621-60", "marketing_start_date": "20211202"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-621-70)", "package_ndc": "71610-621-70", "marketing_start_date": "20220124"}, {"sample": false, "description": "135 TABLET in 1 BOTTLE (71610-621-73)", "package_ndc": "71610-621-73", "marketing_start_date": "20211202"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-621-80)", "package_ndc": "71610-621-80", "marketing_start_date": "20211217"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (71610-621-92)", "package_ndc": "71610-621-92", "marketing_start_date": "20211202"}, {"sample": false, "description": "360 TABLET in 1 BOTTLE (71610-621-94)", "package_ndc": "71610-621-94", "marketing_start_date": "20220124"}], "brand_name": "GABAPENTIN", "product_id": "71610-621_bc931d95-28ae-405b-ad93-e1fe0b51eab9", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-621", "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": "ANDA214957", "marketing_category": "ANDA", "marketing_start_date": "20211001", "listing_expiration_date": "20261231"}