gabapentin

Generic: gabapentin

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

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gabapentin 800 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-127
Product ID 68462-127_4da1bae0-701b-4b65-a01e-f4bcedfad849
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077662
Listing Expiration 2026-12-31
Marketing Start 2006-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462127
Hyphenated Format 68462-127

Supplemental Identifiers

RxCUI
310433 310434
UPC
0368462127018 0368462126011
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 ANDA077662 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68462-127-01)
  • 500 TABLET in 1 BOTTLE (68462-127-05)
source: ndc

Packages (2)

68462-127-01 100 TABLET in 1 BOTTLE (68462-127-01) 68462-127-05 500 TABLET in 1 BOTTLE (68462-127-05)

Ingredients (1)

gabapentin (800 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": "4da1bae0-701b-4b65-a01e-f4bcedfad849", "openfda": {"nui": ["N0000008486"], "upc": ["0368462127018", "0368462126011"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["3865a6e3-112c-490c-82ac-35401336b16e"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68462-127-01)", "package_ndc": "68462-127-01", "marketing_start_date": "20060401"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68462-127-05)", "package_ndc": "68462-127-05", "marketing_start_date": "20060401"}], "brand_name": "Gabapentin", "product_id": "68462-127_4da1bae0-701b-4b65-a01e-f4bcedfad849", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68462-127", "generic_name": "Gabapentin", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA077662", "marketing_category": "ANDA", "marketing_start_date": "20060401", "listing_expiration_date": "20261231"}