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 CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-943
Product ID 69097-943_fdeea2da-e306-45d8-a27a-e8be090319ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090705
Listing Expiration 2026-12-31
Marketing Start 2017-12-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097943
Hyphenated Format 69097-943

Supplemental Identifiers

RxCUI
310430 310431 310432
UPC
0369097815073 0369097813079 0369097943073 0369097814076
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 ANDA090705 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (69097-943-07)
  • 500 CAPSULE in 1 BOTTLE (69097-943-12)
source: ndc

Packages (2)

69097-943-07 100 CAPSULE in 1 BOTTLE (69097-943-07) 69097-943-12 500 CAPSULE in 1 BOTTLE (69097-943-12)

Ingredients (1)

gabapentin (300 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": "fdeea2da-e306-45d8-a27a-e8be090319ea", "openfda": {"nui": ["N0000008486"], "upc": ["0369097815073", "0369097813079", "0369097943073", "0369097814076"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432"], "spl_set_id": ["9e4eca9c-6a2c-4ede-a252-1a27094bf594"], "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": "100 CAPSULE in 1 BOTTLE (69097-943-07)", "package_ndc": "69097-943-07", "marketing_start_date": "20171205"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (69097-943-12)", "package_ndc": "69097-943-12", "marketing_start_date": "20171205"}], "brand_name": "GABAPENTIN", "product_id": "69097-943_fdeea2da-e306-45d8-a27a-e8be090319ea", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69097-943", "generic_name": "GABAPENTIN", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GABAPENTIN", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "ANDA090705", "marketing_category": "ANDA", "marketing_start_date": "20171205", "listing_expiration_date": "20261231"}