gabapentin

Generic: gabapentin

Labeler: bi-coastal pharma international llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler bi-coastal pharma international llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 400 mg/1

Manufacturer
Bi-Coastal Pharma International LLC

Identifiers & Regulatory

Product NDC 42582-116
Product ID 42582-116_2623362f-c5cd-4880-bb49-2d64bedf7be0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090007
Listing Expiration 2026-12-31
Marketing Start 2016-04-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42582116
Hyphenated Format 42582-116

Supplemental Identifiers

RxCUI
310430 310431 310432
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 ANDA090007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (42582-116-10)
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (42582-116-18)
source: ndc

Packages (2)

42582-116-10 100 CAPSULE in 1 BOTTLE, PLASTIC (42582-116-10) 42582-116-18 500 CAPSULE in 1 BOTTLE, PLASTIC (42582-116-18)

Ingredients (1)

gabapentin (400 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": "2623362f-c5cd-4880-bb49-2d64bedf7be0", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432"], "spl_set_id": ["e0cd96d1-b1ef-46ec-a5a3-9505b0811b8b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Bi-Coastal Pharma International LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (42582-116-10)", "package_ndc": "42582-116-10", "marketing_start_date": "20160413"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (42582-116-18)", "package_ndc": "42582-116-18", "marketing_start_date": "20160413"}], "brand_name": "Gabapentin", "product_id": "42582-116_2623362f-c5cd-4880-bb49-2d64bedf7be0", "dosage_form": "CAPSULE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "42582-116", "generic_name": "Gabapentin", "labeler_name": "Bi-Coastal Pharma International LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "400 mg/1"}], "application_number": "ANDA090007", "marketing_category": "ANDA", "marketing_start_date": "20160413", "listing_expiration_date": "20261231"}