gabapentin

Generic: gabapentin

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gabapentin 600 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-226
Product ID 16571-226_e4b713f1-a833-4fc7-8a0f-696077ddc280
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217995
Listing Expiration 2026-12-31
Marketing Start 2024-04-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571226
Hyphenated Format 16571-226

Supplemental Identifiers

RxCUI
310433
UPC
0316571226016
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 ANDA217995 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16571-226-01)
  • 500 TABLET in 1 BOTTLE (16571-226-50)
source: ndc

Packages (2)

16571-226-01 100 TABLET in 1 BOTTLE (16571-226-01) 16571-226-50 500 TABLET in 1 BOTTLE (16571-226-50)

Ingredients (1)

gabapentin (600 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": "e4b713f1-a833-4fc7-8a0f-696077ddc280", "openfda": {"nui": ["N0000008486"], "upc": ["0316571226016"], "unii": ["6CW7F3G59X"], "rxcui": ["310433"], "spl_set_id": ["8215da86-d7af-4980-b6d6-4bd46f6bfeaf"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16571-226-01)", "package_ndc": "16571-226-01", "marketing_start_date": "20240404"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16571-226-50)", "package_ndc": "16571-226-50", "marketing_start_date": "20240404"}], "brand_name": "Gabapentin", "product_id": "16571-226_e4b713f1-a833-4fc7-8a0f-696077ddc280", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "16571-226", "generic_name": "Gabapentin", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "600 mg/1"}], "application_number": "ANDA217995", "marketing_category": "ANDA", "marketing_start_date": "20240404", "listing_expiration_date": "20261231"}