gabapentin

Generic: gabapentin

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

Drug Facts

Product Profile

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

gabapentin 800 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-205
Product ID 68382-205_e85a763f-472b-492b-bf25-a30251b9b50b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078926
Listing Expiration 2026-12-31
Marketing Start 2012-10-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382205
Hyphenated Format 68382-205

Supplemental Identifiers

RxCUI
310433 310434
UPC
0368382204011 0368382205018
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 ANDA078926 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68382-205-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (68382-205-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68382-205-10)
  • 100 BLISTER PACK in 1 CARTON (68382-205-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-205-30)
source: ndc

Packages (4)

68382-205-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-205-01) 68382-205-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-205-05) 68382-205-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-205-10) 68382-205-77 100 BLISTER PACK in 1 CARTON (68382-205-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-205-30)

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": "e85a763f-472b-492b-bf25-a30251b9b50b", "openfda": {"nui": ["N0000008486"], "upc": ["0368382204011", "0368382205018"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["310ce005-5a24-489a-b23c-d42ab6a3bfed"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-205-01)", "package_ndc": "68382-205-01", "marketing_start_date": "20121016"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68382-205-05)", "package_ndc": "68382-205-05", "marketing_start_date": "20121016"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-205-10)", "package_ndc": "68382-205-10", "marketing_start_date": "20121016"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (68382-205-77)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-205-30)", "package_ndc": "68382-205-77", "marketing_start_date": "20121016"}], "brand_name": "Gabapentin", "product_id": "68382-205_e85a763f-472b-492b-bf25-a30251b9b50b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68382-205", "generic_name": "Gabapentin", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA078926", "marketing_category": "ANDA", "marketing_start_date": "20121016", "listing_expiration_date": "20261231"}