gabapentin

Generic: gabapentin

Labeler: laurus labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler laurus labs limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gabapentin 800 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-980
Product ID 42385-980_7a649a0a-d3ca-48e4-af76-f9adf3fa6c4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217965
Listing Expiration 2026-12-31
Marketing Start 2024-04-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42385980
Hyphenated Format 42385-980

Supplemental Identifiers

RxCUI
310430 310431 310432 310433 310434
UPC
0342385980301
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 ANDA217965 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42385-980-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (42385-980-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (42385-980-11)
  • 30 TABLET, FILM COATED in 1 BOTTLE (42385-980-30)
  • 10 BLISTER PACK in 1 CARTON (42385-980-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 90 TABLET, FILM COATED in 1 BOTTLE (42385-980-90)
source: ndc

Packages (6)

42385-980-01 100 TABLET, FILM COATED in 1 BOTTLE (42385-980-01) 42385-980-05 500 TABLET, FILM COATED in 1 BOTTLE (42385-980-05) 42385-980-11 1000 TABLET, FILM COATED in 1 BOTTLE (42385-980-11) 42385-980-30 30 TABLET, FILM COATED in 1 BOTTLE (42385-980-30) 42385-980-72 10 BLISTER PACK in 1 CARTON (42385-980-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK 42385-980-90 90 TABLET, FILM COATED in 1 BOTTLE (42385-980-90)

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": "7a649a0a-d3ca-48e4-af76-f9adf3fa6c4d", "openfda": {"nui": ["N0000008486"], "upc": ["0342385980301"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432", "310433", "310434"], "spl_set_id": ["07aa1bcc-df05-44fa-92d4-63894e0e6cd6"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42385-980-01)", "package_ndc": "42385-980-01", "marketing_start_date": "20240409"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42385-980-05)", "package_ndc": "42385-980-05", "marketing_start_date": "20240409"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (42385-980-11)", "package_ndc": "42385-980-11", "marketing_start_date": "20240409"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42385-980-30)", "package_ndc": "42385-980-30", "marketing_start_date": "20240409"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (42385-980-72)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "42385-980-72", "marketing_start_date": "20240409"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42385-980-90)", "package_ndc": "42385-980-90", "marketing_start_date": "20240409"}], "brand_name": "Gabapentin", "product_id": "42385-980_7a649a0a-d3ca-48e4-af76-f9adf3fa6c4d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "42385-980", "generic_name": "Gabapentin", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA217965", "marketing_category": "ANDA", "marketing_start_date": "20240409", "listing_expiration_date": "20261231"}