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 300 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-088
Product ID 71610-088_0515dc32-e7fc-4208-9677-ec9dfad018f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090007
Listing Expiration 2026-12-31
Marketing Start 2015-12-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610088
Hyphenated Format 71610-088

Supplemental Identifiers

RxCUI
310431
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 ANDA090007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (71610-088-53)
  • 90 CAPSULE in 1 BOTTLE (71610-088-60)
  • 180 CAPSULE in 1 BOTTLE (71610-088-80)
  • 270 CAPSULE in 1 BOTTLE (71610-088-92)
  • 360 CAPSULE in 1 BOTTLE (71610-088-94)
source: ndc

Packages (5)

71610-088-53 60 CAPSULE in 1 BOTTLE (71610-088-53) 71610-088-60 90 CAPSULE in 1 BOTTLE (71610-088-60) 71610-088-80 180 CAPSULE in 1 BOTTLE (71610-088-80) 71610-088-92 270 CAPSULE in 1 BOTTLE (71610-088-92) 71610-088-94 360 CAPSULE in 1 BOTTLE (71610-088-94)

Ingredients (1)

gabapentin (300 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": "0515dc32-e7fc-4208-9677-ec9dfad018f1", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310431"], "spl_set_id": ["9d1b9121-c25a-4d28-91c5-5fc72f1167f4"], "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 (71610-088-53)", "package_ndc": "71610-088-53", "marketing_start_date": "20180621"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-088-60)", "package_ndc": "71610-088-60", "marketing_start_date": "20180621"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (71610-088-80)", "package_ndc": "71610-088-80", "marketing_start_date": "20180621"}, {"sample": false, "description": "270 CAPSULE in 1 BOTTLE (71610-088-92)", "package_ndc": "71610-088-92", "marketing_start_date": "20180621"}, {"sample": false, "description": "360 CAPSULE in 1 BOTTLE (71610-088-94)", "package_ndc": "71610-088-94", "marketing_start_date": "20180621"}], "brand_name": "GABAPENTIN", "product_id": "71610-088_0515dc32-e7fc-4208-9677-ec9dfad018f1", "dosage_form": "CAPSULE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-088", "generic_name": "GABAPENTIN", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GABAPENTIN", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "ANDA090007", "marketing_category": "ANDA", "marketing_start_date": "20151230", "listing_expiration_date": "20261231"}