gabapentin

Generic: gabapentin

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler advanced rx of tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
ADVANCED RX OF TENNESSEE, LLC

Identifiers & Regulatory

Product NDC 80425-0031
Product ID 80425-0031_2a988314-623a-2d61-e063-6294a90a3e84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206943
Listing Expiration 2026-12-31
Marketing Start 2018-05-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250031
Hyphenated Format 80425-0031

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 ANDA206943 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (80425-0031-1)
  • 60 CAPSULE in 1 BOTTLE (80425-0031-2)
  • 90 CAPSULE in 1 BOTTLE (80425-0031-3)
  • 120 CAPSULE in 1 BOTTLE (80425-0031-4)
source: ndc

Packages (4)

80425-0031-1 30 CAPSULE in 1 BOTTLE (80425-0031-1) 80425-0031-2 60 CAPSULE in 1 BOTTLE (80425-0031-2) 80425-0031-3 90 CAPSULE in 1 BOTTLE (80425-0031-3) 80425-0031-4 120 CAPSULE in 1 BOTTLE (80425-0031-4)

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": "2a988314-623a-2d61-e063-6294a90a3e84", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310431"], "spl_set_id": ["af73fbd8-9731-e6bf-e053-2995a90af65d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["ADVANCED RX OF TENNESSEE, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (80425-0031-1)", "package_ndc": "80425-0031-1", "marketing_start_date": "20180514"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (80425-0031-2)", "package_ndc": "80425-0031-2", "marketing_start_date": "20180514"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (80425-0031-3)", "package_ndc": "80425-0031-3", "marketing_start_date": "20180514"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (80425-0031-4)", "package_ndc": "80425-0031-4", "marketing_start_date": "20230330"}], "brand_name": "Gabapentin", "product_id": "80425-0031_2a988314-623a-2d61-e063-6294a90a3e84", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "80425-0031", "generic_name": "Gabapentin", "labeler_name": "ADVANCED RX OF TENNESSEE, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "ANDA206943", "marketing_category": "ANDA", "marketing_start_date": "20180514", "listing_expiration_date": "20261231"}