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 100 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-421
Product ID 71610-421_21d2a6c0-a9bc-4a72-aca2-86a7e840c914
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 71610421
Hyphenated Format 71610-421

Supplemental Identifiers

RxCUI
310430
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
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-30)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-53)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-60)
  • 180 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-80)
source: ndc

Packages (4)

71610-421-30 30 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-30) 71610-421-53 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-53) 71610-421-60 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-60) 71610-421-80 180 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-80)

Ingredients (1)

gabapentin (100 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": "21d2a6c0-a9bc-4a72-aca2-86a7e840c914", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310430"], "spl_set_id": ["20e48004-d8b6-40fd-929b-b95087b4d85d"], "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 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-30)", "package_ndc": "71610-421-30", "marketing_start_date": "20200729"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-53)", "package_ndc": "71610-421-53", "marketing_start_date": "20200501"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-60)", "package_ndc": "71610-421-60", "marketing_start_date": "20221017"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE, PLASTIC (71610-421-80)", "package_ndc": "71610-421-80", "marketing_start_date": "20221123"}], "brand_name": "Gabapentin", "product_id": "71610-421_21d2a6c0-a9bc-4a72-aca2-86a7e840c914", "dosage_form": "CAPSULE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-421", "generic_name": "Gabapentin", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "100 mg/1"}], "application_number": "ANDA204989", "marketing_category": "ANDA", "marketing_start_date": "20160218", "listing_expiration_date": "20261231"}