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 800 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-117
Product ID 16571-117_20c65bad-52d5-462e-aa17-5b7320f92b76
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217995
Listing Expiration 2026-12-31
Marketing Start 2023-07-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571117
Hyphenated Format 16571-117

Supplemental Identifiers

RxCUI
310433 310434
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
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16571-117-01)
  • 500 TABLET in 1 BOTTLE (16571-117-50)
source: ndc

Packages (2)

16571-117-01 100 TABLET in 1 BOTTLE (16571-117-01) 16571-117-50 500 TABLET in 1 BOTTLE (16571-117-50)

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": "20c65bad-52d5-462e-aa17-5b7320f92b76", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["b1a9808d-31a5-4b63-afd0-d96d5a0ad7a1"], "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 (16571-117-01)", "package_ndc": "16571-117-01", "marketing_start_date": "20230719"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16571-117-50)", "package_ndc": "16571-117-50", "marketing_start_date": "20230719"}], "brand_name": "Gabapentin", "product_id": "16571-117_20c65bad-52d5-462e-aa17-5b7320f92b76", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "16571-117", "generic_name": "Gabapentin", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA217995", "marketing_category": "ANDA", "marketing_start_date": "20230719", "listing_expiration_date": "20261231"}