gabapentin

Generic: gabapentin

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

Drug Facts

Product Profile

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

gabapentin 800 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-228
Product ID 70010-228_3513f676-25fe-02db-e063-6294a90a1f9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217116
Listing Expiration 2026-12-31
Marketing Start 2023-06-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70010228
Hyphenated Format 70010-228

Supplemental Identifiers

RxCUI
310433 310434
UPC
0370010228016 0370010227019
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 ANDA217116 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (70010-228-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (70010-228-05)
source: ndc

Packages (2)

70010-228-01 100 TABLET, FILM COATED in 1 BOTTLE (70010-228-01) 70010-228-05 500 TABLET, FILM COATED in 1 BOTTLE (70010-228-05)

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": "3513f676-25fe-02db-e063-6294a90a1f9d", "openfda": {"nui": ["N0000008486"], "upc": ["0370010228016", "0370010227019"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["e847bcfa-f3de-404a-8a57-d8a414691e6a"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70010-228-01)", "package_ndc": "70010-228-01", "marketing_start_date": "20230627"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (70010-228-05)", "package_ndc": "70010-228-05", "marketing_start_date": "20230627"}], "brand_name": "Gabapentin", "product_id": "70010-228_3513f676-25fe-02db-e063-6294a90a1f9d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70010-228", "generic_name": "Gabapentin", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA217116", "marketing_category": "ANDA", "marketing_start_date": "20230627", "listing_expiration_date": "20261231"}