gabapentin

Generic: gabapentin

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

gabapentin 800 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-412
Product ID 68001-412_3e4d1b97-0022-6671-e063-6294a90ae02d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077662
Listing Expiration 2026-12-31
Marketing Start 2019-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001412
Hyphenated Format 68001-412

Supplemental Identifiers

RxCUI
310433 310434
UPC
0368001412001 0368001411004
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 (68001-412-00)
  • 500 TABLET in 1 BOTTLE (68001-412-03)
source: ndc

Packages (2)

68001-412-00 100 TABLET in 1 BOTTLE (68001-412-00) 68001-412-03 500 TABLET in 1 BOTTLE (68001-412-03)

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": "3e4d1b97-0022-6671-e063-6294a90ae02d", "openfda": {"nui": ["N0000008486"], "upc": ["0368001412001", "0368001411004"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["3368bf70-d466-4765-b2b7-7fe967a8c2b7"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68001-412-00)", "package_ndc": "68001-412-00", "marketing_start_date": "20190930"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68001-412-03)", "package_ndc": "68001-412-03", "marketing_start_date": "20190930"}], "brand_name": "Gabapentin", "product_id": "68001-412_3e4d1b97-0022-6671-e063-6294a90ae02d", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68001-412", "generic_name": "Gabapentin", "labeler_name": "BluePoint Laboratories", "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": "20190930", "listing_expiration_date": "20261231"}