gabapentin

Generic: gabapentin

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler teva pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3495
Product ID 0480-3495_dd7c765d-6e13-4b89-a583-9754cc972a15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075350
Listing Expiration 2027-12-31
Marketing Start 2026-01-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04803495
Hyphenated Format 0480-3495

Supplemental Identifiers

RxCUI
310430 310431
UNII
6CW7F3G59X
NUI
N0000008486

Packaging Origin

Original Packager
true

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 ANDA075350 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (0480-3495-05)
source: ndc

Packages (1)

0480-3495-05 500 CAPSULE in 1 BOTTLE (0480-3495-05)

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": "dd7c765d-6e13-4b89-a583-9754cc972a15", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431"], "spl_set_id": ["c7f21eaa-68ee-420c-9c98-e997cc73a297"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (0480-3495-05)", "package_ndc": "0480-3495-05", "marketing_start_date": "20260112"}], "brand_name": "Gabapentin", "product_id": "0480-3495_dd7c765d-6e13-4b89-a583-9754cc972a15", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0480-3495", "generic_name": "Gabapentin", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "ANDA075350", "marketing_category": "ANDA", "marketing_start_date": "20260112", "listing_expiration_date": "20271231"}