gabapentin

Generic: gabapentin

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler coupler llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 400 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1591
Product ID 67046-1591_3eeda928-8d25-1afd-e063-6294a90a7901
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207099
Listing Expiration 2026-12-31
Marketing Start 2025-09-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461591
Hyphenated Format 67046-1591

Supplemental Identifiers

RxCUI
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 ANDA207099 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (67046-1591-3)
source: ndc

Packages (1)

67046-1591-3 30 CAPSULE in 1 BLISTER PACK (67046-1591-3)

Ingredients (1)

gabapentin (400 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": "3eeda928-8d25-1afd-e063-6294a90a7901", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310432"], "spl_set_id": ["3eeda97d-c3cd-65cd-e063-6394a90aae8b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (67046-1591-3)", "package_ndc": "67046-1591-3", "marketing_start_date": "20250916"}], "brand_name": "gabapentin", "product_id": "67046-1591_3eeda928-8d25-1afd-e063-6294a90a7901", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "67046-1591", "generic_name": "gabapentin", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "400 mg/1"}], "application_number": "ANDA207099", "marketing_category": "ANDA", "marketing_start_date": "20250916", "listing_expiration_date": "20261231"}