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 71610-753
Product ID 71610-753_9f1cfdaf-a07f-4f37-9f9c-695cafe6cfee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214956
Listing Expiration 2026-12-31
Marketing Start 2021-05-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610753
Hyphenated Format 71610-753

Supplemental Identifiers

RxCUI
310430 310431 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 ANDA214956 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 120 CAPSULE in 1 BOTTLE (71610-753-70)
  • 360 CAPSULE in 1 BOTTLE (71610-753-94)
  • 540 CAPSULE in 1 BOTTLE (71610-753-98)
source: ndc

Packages (3)

71610-753-70 120 CAPSULE in 1 BOTTLE (71610-753-70) 71610-753-94 360 CAPSULE in 1 BOTTLE (71610-753-94) 71610-753-98 540 CAPSULE in 1 BOTTLE (71610-753-98)

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": "9f1cfdaf-a07f-4f37-9f9c-695cafe6cfee", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432"], "spl_set_id": ["f38098ec-dd1a-405a-bbfb-bad62e4e7fa5"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE (71610-753-70)", "package_ndc": "71610-753-70", "marketing_start_date": "20231130"}, {"sample": false, "description": "360 CAPSULE in 1 BOTTLE (71610-753-94)", "package_ndc": "71610-753-94", "marketing_start_date": "20231116"}, {"sample": false, "description": "540 CAPSULE in 1 BOTTLE (71610-753-98)", "package_ndc": "71610-753-98", "marketing_start_date": "20231208"}], "brand_name": "GABAPENTIN", "product_id": "71610-753_9f1cfdaf-a07f-4f37-9f9c-695cafe6cfee", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71610-753", "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": "ANDA214956", "marketing_category": "ANDA", "marketing_start_date": "20210510", "listing_expiration_date": "20261231"}