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 CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 400 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-631
Product ID 71610-631_2b5aee3a-519c-0872-e063-6294a90a1bb9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204989
Listing Expiration 2026-12-31
Marketing Start 2016-02-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610631
Hyphenated Format 71610-631

Supplemental Identifiers

RxCUI
310432
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 ANDA204989 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-53)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-60)
  • 180 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-80)
  • 270 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-92)
source: ndc

Packages (4)

71610-631-53 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-53) 71610-631-60 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-60) 71610-631-80 180 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-80) 71610-631-92 270 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-92)

Ingredients (1)

gabapentin (400 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": "2b5aee3a-519c-0872-e063-6294a90a1bb9", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310432"], "spl_set_id": ["95757436-2093-41cf-a9a9-ef2f28ac096f"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-53)", "package_ndc": "71610-631-53", "marketing_start_date": "20220131"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-60)", "package_ndc": "71610-631-60", "marketing_start_date": "20220131"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-80)", "package_ndc": "71610-631-80", "marketing_start_date": "20220131"}, {"sample": false, "description": "270 CAPSULE in 1 BOTTLE, PLASTIC (71610-631-92)", "package_ndc": "71610-631-92", "marketing_start_date": "20220131"}], "brand_name": "Gabapentin", "product_id": "71610-631_2b5aee3a-519c-0872-e063-6294a90a1bb9", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-631", "generic_name": "Gabapentin", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "400 mg/1"}], "application_number": "ANDA204989", "marketing_category": "ANDA", "marketing_start_date": "20160218", "listing_expiration_date": "20261231"}