gabapentin

Generic: gabapentin

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gabapentin 800 mg/1

Manufacturer
QUALLENT PHARMACEUTICALS HEALTH LLC

Identifiers & Regulatory

Product NDC 82009-072
Product ID 82009-072_f3eaa220-daf6-41ed-a5a2-4656c4a389d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200651
Listing Expiration 2026-12-31
Marketing Start 2023-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009072
Hyphenated Format 82009-072

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 ANDA200651 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (82009-072-05)
source: ndc

Packages (1)

82009-072-05 500 TABLET, FILM COATED in 1 BOTTLE (82009-072-05)

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": "f3eaa220-daf6-41ed-a5a2-4656c4a389d9", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["472bb279-bb4e-4246-b2a3-172483ba356b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["QUALLENT PHARMACEUTICALS HEALTH LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (82009-072-05)", "package_ndc": "82009-072-05", "marketing_start_date": "20230901"}], "brand_name": "Gabapentin", "product_id": "82009-072_f3eaa220-daf6-41ed-a5a2-4656c4a389d9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "82009-072", "generic_name": "Gabapentin", "labeler_name": "QUALLENT PHARMACEUTICALS HEALTH LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA200651", "marketing_category": "ANDA", "marketing_start_date": "20230901", "listing_expiration_date": "20261231"}