gabapentin

Generic: gabapentin

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

Drug Facts

Product Profile

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

gabapentin 800 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3523
Product ID 68071-3523_2d3f8d53-7482-27fd-e063-6294a90a2171
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207057
Listing Expiration 2026-12-31
Marketing Start 2021-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713523
Hyphenated Format 68071-3523

Supplemental Identifiers

RxCUI
310434
UPC
0368071352399
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 ANDA207057 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 90 TABLET, COATED in 1 BOTTLE, PLASTIC (68071-3523-9)
source: ndc

Packages (1)

68071-3523-9 90 TABLET, COATED in 1 BOTTLE, PLASTIC (68071-3523-9)

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": "2d3f8d53-7482-27fd-e063-6294a90a2171", "openfda": {"nui": ["N0000008486"], "upc": ["0368071352399"], "unii": ["6CW7F3G59X"], "rxcui": ["310434"], "spl_set_id": ["07871ab8-254b-e3c2-e063-6294a90a29ab"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE, PLASTIC (68071-3523-9)", "package_ndc": "68071-3523-9", "marketing_start_date": "20231012"}], "brand_name": "Gabapentin", "product_id": "68071-3523_2d3f8d53-7482-27fd-e063-6294a90a2171", "dosage_form": "TABLET, COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68071-3523", "generic_name": "Gabapentin", "labeler_name": "NuCare Pharmaceuticals,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": "20211101", "listing_expiration_date": "20261231"}