gabapentin

Generic: gabapentin

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler mylan pharmaceuticals inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

gabapentin 250 mg/5mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-5050
Product ID 59762-5050_f5c6e992-4771-4c56-ac1f-00ccfb88bef5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021129
Listing Expiration 2026-12-31
Marketing Start 2022-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 597625050
Hyphenated Format 59762-5050

Supplemental Identifiers

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 NDA021129 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (59762-5050-7) / 470 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

59762-5050-7 1 BOTTLE, PLASTIC in 1 CARTON (59762-5050-7) / 470 mL in 1 BOTTLE, PLASTIC

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": "f5c6e992-4771-4c56-ac1f-00ccfb88bef5", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "spl_set_id": ["cff7de45-148b-4e96-88fd-6052bf75b5f7"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (59762-5050-7)  / 470 mL in 1 BOTTLE, PLASTIC", "package_ndc": "59762-5050-7", "marketing_start_date": "20220701"}], "brand_name": "GABAPENTIN", "product_id": "59762-5050_f5c6e992-4771-4c56-ac1f-00ccfb88bef5", "dosage_form": "SUSPENSION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "59762-5050", "generic_name": "gabapentin", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GABAPENTIN", "active_ingredients": [{"name": "GABAPENTIN", "strength": "250 mg/5mL"}], "application_number": "NDA021129", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20220701", "listing_expiration_date": "20261231"}