gabapentin

Generic: gabapentin

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

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler biocomp pharma, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

gabapentin 250 mg/5mL

Manufacturer
BioComp Pharma, Inc.

Identifiers & Regulatory

Product NDC 44523-120
Product ID 44523-120_462c7cf4-92a8-cf81-e063-6294a90a43c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078974
Listing Expiration 2026-12-31
Marketing Start 2023-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 44523120
Hyphenated Format 44523-120

Supplemental Identifiers

RxCUI
283523
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 ANDA078974 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 470 mL in 1 BOTTLE (44523-120-16)
source: ndc

Packages (1)

44523-120-16 470 mL in 1 BOTTLE (44523-120-16)

Ingredients (1)

gabapentin (250 mg/5mL)

Linked Drug Pages (1)

Gabapentin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "462c7cf4-92a8-cf81-e063-6294a90a43c3", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["283523"], "spl_set_id": ["0b3a4009-42f3-c84f-e063-6294a90a8068"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["BioComp Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "470 mL in 1 BOTTLE (44523-120-16)", "package_ndc": "44523-120-16", "marketing_start_date": "20231130"}], "brand_name": "Gabapentin", "product_id": "44523-120_462c7cf4-92a8-cf81-e063-6294a90a43c3", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "44523-120", "generic_name": "Gabapentin", "labeler_name": "BioComp Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "250 mg/5mL"}], "application_number": "ANDA078974", "marketing_category": "ANDA", "marketing_start_date": "20231130", "listing_expiration_date": "20261231"}