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 71610-044
Product ID 71610-044_a695e055-6531-4b51-969f-62165d703511
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 71610044
Hyphenated Format 71610-044

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 ANDA203244 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-044-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-044-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-044-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-044-60)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71610-044-70)
  • 135 TABLET, FILM COATED in 1 BOTTLE (71610-044-73)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71610-044-80)
  • 270 TABLET, FILM COATED in 1 BOTTLE (71610-044-92)
source: ndc

Packages (8)

71610-044-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-044-30) 71610-044-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-044-45) 71610-044-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-044-53) 71610-044-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-044-60) 71610-044-70 120 TABLET, FILM COATED in 1 BOTTLE (71610-044-70) 71610-044-73 135 TABLET, FILM COATED in 1 BOTTLE (71610-044-73) 71610-044-80 180 TABLET, FILM COATED in 1 BOTTLE (71610-044-80) 71610-044-92 270 TABLET, FILM COATED in 1 BOTTLE (71610-044-92)

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": "a695e055-6531-4b51-969f-62165d703511", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433"], "spl_set_id": ["39149f0e-30ed-4671-8be7-2a484f65d63b"], "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, FILM COATED in 1 BOTTLE (71610-044-30)", "package_ndc": "71610-044-30", "marketing_start_date": "20200610"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-044-45)", "package_ndc": "71610-044-45", "marketing_start_date": "20200610"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-044-53)", "package_ndc": "71610-044-53", "marketing_start_date": "20200610"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-044-60)", "package_ndc": "71610-044-60", "marketing_start_date": "20180323"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71610-044-70)", "package_ndc": "71610-044-70", "marketing_start_date": "20200730"}, {"sample": false, "description": "135 TABLET, FILM COATED in 1 BOTTLE (71610-044-73)", "package_ndc": "71610-044-73", "marketing_start_date": "20200730"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71610-044-80)", "package_ndc": "71610-044-80", "marketing_start_date": "20180323"}, {"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (71610-044-92)", "package_ndc": "71610-044-92", "marketing_start_date": "20180323"}], "brand_name": "Gabapentin", "product_id": "71610-044_a695e055-6531-4b51-969f-62165d703511", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-044", "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": "ANDA203244", "marketing_category": "ANDA", "marketing_start_date": "20140111", "listing_expiration_date": "20261231"}