gabapentin

Generic: gabapentin

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gabapentin 800 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-394
Product ID 72189-394_3725f1c1-dc68-6231-e063-6394a90aaec9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214957
Listing Expiration 2026-12-31
Marketing Start 2022-11-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189394
Hyphenated Format 72189-394

Supplemental Identifiers

RxCUI
310434
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 ANDA214957 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-394-30)
  • 60 TABLET in 1 BOTTLE (72189-394-60)
  • 120 TABLET in 1 BOTTLE (72189-394-72)
  • 90 TABLET in 1 BOTTLE (72189-394-90)
source: ndc

Packages (4)

Ingredients (1)

gabapentin (800 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3725f1c1-dc68-6231-e063-6394a90aaec9", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310434"], "spl_set_id": ["ed9c501c-24e4-da89-e053-2a95a90a64c6"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-394-30)", "package_ndc": "72189-394-30", "marketing_start_date": "20221116"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-394-60)", "package_ndc": "72189-394-60", "marketing_start_date": "20221116"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (72189-394-72)", "package_ndc": "72189-394-72", "marketing_start_date": "20221116"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-394-90)", "package_ndc": "72189-394-90", "marketing_start_date": "20221116"}], "brand_name": "Gabapentin", "product_id": "72189-394_3725f1c1-dc68-6231-e063-6394a90aaec9", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72189-394", "generic_name": "Gabapentin", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA214957", "marketing_category": "ANDA", "marketing_start_date": "20221116", "listing_expiration_date": "20261231"}