gabapentin

Generic: gabapentin

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler precision dose, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

gabapentin 800 mg/1

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-489
Product ID 68094-489_471ad25b-0c63-489c-9df3-44ea7fdcd256
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207057
Listing Expiration 2026-12-31
Marketing Start 2024-02-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094489
Hyphenated Format 68094-489

Supplemental Identifiers

RxCUI
310433 310434
UPC
0368094589505
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 ANDA207057 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (68094-489-50)
  • 500 TABLET, COATED in 1 BOTTLE (68094-489-60)
source: ndc

Packages (2)

68094-489-50 100 TABLET, COATED in 1 BOTTLE (68094-489-50) 68094-489-60 500 TABLET, COATED in 1 BOTTLE (68094-489-60)

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": "471ad25b-0c63-489c-9df3-44ea7fdcd256", "openfda": {"nui": ["N0000008486"], "upc": ["0368094589505"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["86c93d8b-6286-44e2-93dd-f1b10a5d83da"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Precision Dose, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (68094-489-50)", "package_ndc": "68094-489-50", "marketing_start_date": "20240215"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (68094-489-60)", "package_ndc": "68094-489-60", "marketing_start_date": "20240215"}], "brand_name": "Gabapentin", "product_id": "68094-489_471ad25b-0c63-489c-9df3-44ea7fdcd256", "dosage_form": "TABLET, COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68094-489", "generic_name": "Gabapentin", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA207057", "marketing_category": "ANDA", "marketing_start_date": "20240215", "listing_expiration_date": "20261231"}