gabapentin

Generic: gabapentin

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler cipla usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gabapentin 800 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-811
Product ID 69097-811_69887d93-de9a-4397-a629-a0ce8e62c69a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202764
Listing Expiration 2026-12-31
Marketing Start 2016-07-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097811
Hyphenated Format 69097-811

Supplemental Identifiers

RxCUI
310433 310434
UPC
0369097812072 0369097811075
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 ANDA202764 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (69097-811-02)
  • 100 TABLET in 1 BOTTLE (69097-811-07)
  • 500 TABLET in 1 BOTTLE (69097-811-12)
source: ndc

Packages (3)

69097-811-02 30 TABLET in 1 BOTTLE (69097-811-02) 69097-811-07 100 TABLET in 1 BOTTLE (69097-811-07) 69097-811-12 500 TABLET in 1 BOTTLE (69097-811-12)

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": "69887d93-de9a-4397-a629-a0ce8e62c69a", "openfda": {"nui": ["N0000008486"], "upc": ["0369097812072", "0369097811075"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["7c3ac86f-b8f7-42bf-942a-db854d946e54"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69097-811-02)", "package_ndc": "69097-811-02", "marketing_start_date": "20160722"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (69097-811-07)", "package_ndc": "69097-811-07", "marketing_start_date": "20160722"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69097-811-12)", "package_ndc": "69097-811-12", "marketing_start_date": "20160722"}], "brand_name": "Gabapentin", "product_id": "69097-811_69887d93-de9a-4397-a629-a0ce8e62c69a", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69097-811", "generic_name": "Gabapentin", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA202764", "marketing_category": "ANDA", "marketing_start_date": "20160722", "listing_expiration_date": "20261231"}