gabapentin

Generic: gabapentin

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler amneal pharmaceuticals of new york llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 100 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-101
Product ID 53746-101_10e5f9be-7920-4775-801b-e1c32b996410
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078428
Listing Expiration 2026-12-31
Marketing Start 2009-11-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746101
Hyphenated Format 53746-101

Supplemental Identifiers

RxCUI
310430 310431 310432
UPC
0353746101303 0353746102300 0353746103307
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 ANDA078428 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (53746-101-01)
  • 500 CAPSULE in 1 BOTTLE (53746-101-05)
  • 1000 CAPSULE in 1 BOTTLE (53746-101-10)
  • 30 CAPSULE in 1 BOTTLE (53746-101-30)
source: ndc

Packages (4)

53746-101-01 100 CAPSULE in 1 BOTTLE (53746-101-01) 53746-101-05 500 CAPSULE in 1 BOTTLE (53746-101-05) 53746-101-10 1000 CAPSULE in 1 BOTTLE (53746-101-10) 53746-101-30 30 CAPSULE in 1 BOTTLE (53746-101-30)

Ingredients (1)

gabapentin (100 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": "10e5f9be-7920-4775-801b-e1c32b996410", "openfda": {"nui": ["N0000008486"], "upc": ["0353746101303", "0353746102300", "0353746103307"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432"], "spl_set_id": ["b11dbff5-ceee-4a63-a093-f6efebdc2f6f"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (53746-101-01)", "package_ndc": "53746-101-01", "marketing_start_date": "20091124"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (53746-101-05)", "package_ndc": "53746-101-05", "marketing_start_date": "20091124"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (53746-101-10)", "package_ndc": "53746-101-10", "marketing_start_date": "20091124"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (53746-101-30)", "package_ndc": "53746-101-30", "marketing_start_date": "20091124"}], "brand_name": "Gabapentin", "product_id": "53746-101_10e5f9be-7920-4775-801b-e1c32b996410", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "53746-101", "generic_name": "Gabapentin", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "100 mg/1"}], "application_number": "ANDA078428", "marketing_category": "ANDA", "marketing_start_date": "20091124", "listing_expiration_date": "20261231"}