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 71610-630
Product ID 71610-630_12e0dcb9-e210-413b-9c77-cdeccd600e82
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 71610630
Hyphenated Format 71610-630

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 ANDA214957 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-630-30)
  • 45 TABLET in 1 BOTTLE (71610-630-45)
  • 60 TABLET in 1 BOTTLE (71610-630-53)
  • 90 TABLET in 1 BOTTLE (71610-630-60)
  • 120 TABLET in 1 BOTTLE (71610-630-70)
  • 135 TABLET in 1 BOTTLE (71610-630-73)
  • 180 TABLET in 1 BOTTLE (71610-630-80)
  • 270 TABLET in 1 BOTTLE (71610-630-92)
source: ndc

Packages (8)

71610-630-30 30 TABLET in 1 BOTTLE (71610-630-30) 71610-630-45 45 TABLET in 1 BOTTLE (71610-630-45) 71610-630-53 60 TABLET in 1 BOTTLE (71610-630-53) 71610-630-60 90 TABLET in 1 BOTTLE (71610-630-60) 71610-630-70 120 TABLET in 1 BOTTLE (71610-630-70) 71610-630-73 135 TABLET in 1 BOTTLE (71610-630-73) 71610-630-80 180 TABLET in 1 BOTTLE (71610-630-80) 71610-630-92 270 TABLET in 1 BOTTLE (71610-630-92)

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": "12e0dcb9-e210-413b-9c77-cdeccd600e82", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310434"], "spl_set_id": ["17988b64-723c-488d-befd-3e4e4cc44bd2"], "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 (71610-630-30)", "package_ndc": "71610-630-30", "marketing_start_date": "20220420"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-630-45)", "package_ndc": "71610-630-45", "marketing_start_date": "20220420"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-630-53)", "package_ndc": "71610-630-53", "marketing_start_date": "20220420"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-630-60)", "package_ndc": "71610-630-60", "marketing_start_date": "20220420"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-630-70)", "package_ndc": "71610-630-70", "marketing_start_date": "20220420"}, {"sample": false, "description": "135 TABLET in 1 BOTTLE (71610-630-73)", "package_ndc": "71610-630-73", "marketing_start_date": "20220420"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-630-80)", "package_ndc": "71610-630-80", "marketing_start_date": "20220125"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (71610-630-92)", "package_ndc": "71610-630-92", "marketing_start_date": "20220125"}], "brand_name": "GABAPENTIN", "product_id": "71610-630_12e0dcb9-e210-413b-9c77-cdeccd600e82", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-630", "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": "ANDA214957", "marketing_category": "ANDA", "marketing_start_date": "20211001", "listing_expiration_date": "20261231"}