gabapentin

Generic: gabapentin

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler preferred pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 400 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8546
Product ID 68788-8546_36a7e397-b4ca-40b3-90ca-b1e5fd33aff9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207099
Listing Expiration 2026-12-31
Marketing Start 2023-11-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888546
Hyphenated Format 68788-8546

Supplemental Identifiers

RxCUI
310432
UNII
6CW7F3G59X
NUI
N0000008486

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 ANDA207099 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68788-8546-1)
  • 30 CAPSULE in 1 BOTTLE (68788-8546-3)
  • 60 CAPSULE in 1 BOTTLE (68788-8546-6)
  • 120 CAPSULE in 1 BOTTLE (68788-8546-8)
  • 90 CAPSULE in 1 BOTTLE (68788-8546-9)
source: ndc

Packages (5)

68788-8546-1 100 CAPSULE in 1 BOTTLE (68788-8546-1) 68788-8546-3 30 CAPSULE in 1 BOTTLE (68788-8546-3) 68788-8546-6 60 CAPSULE in 1 BOTTLE (68788-8546-6) 68788-8546-8 120 CAPSULE in 1 BOTTLE (68788-8546-8) 68788-8546-9 90 CAPSULE in 1 BOTTLE (68788-8546-9)

Ingredients (1)

gabapentin (400 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": "36a7e397-b4ca-40b3-90ca-b1e5fd33aff9", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310432"], "spl_set_id": ["78e478bf-1aa2-47c5-9aa6-bcb35c9674b9"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68788-8546-1)", "package_ndc": "68788-8546-1", "marketing_start_date": "20231107"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68788-8546-3)", "package_ndc": "68788-8546-3", "marketing_start_date": "20231107"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68788-8546-6)", "package_ndc": "68788-8546-6", "marketing_start_date": "20231107"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (68788-8546-8)", "package_ndc": "68788-8546-8", "marketing_start_date": "20231107"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68788-8546-9)", "package_ndc": "68788-8546-9", "marketing_start_date": "20231107"}], "brand_name": "Gabapentin", "product_id": "68788-8546_36a7e397-b4ca-40b3-90ca-b1e5fd33aff9", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68788-8546", "generic_name": "Gabapentin", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "400 mg/1"}], "application_number": "ANDA207099", "marketing_category": "ANDA", "marketing_start_date": "20231107", "listing_expiration_date": "20261231"}