gabapentin

Generic: gabapentin

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gabapentin 800 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-429
Product ID 67877-429_280c139f-c3a2-46e4-b990-ce3808166e86
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206402
Listing Expiration 2026-12-31
Marketing Start 2015-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877429
Hyphenated Format 67877-429

Supplemental Identifiers

RxCUI
310433 310434
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 ANDA206402 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (67877-429-01)
  • 500 TABLET in 1 BOTTLE (67877-429-05)
  • 1000 TABLET in 1 BOTTLE (67877-429-10)
  • 100 BLISTER PACK in 1 CARTON (67877-429-38) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (4)

67877-429-01 100 TABLET in 1 BOTTLE (67877-429-01) 67877-429-05 500 TABLET in 1 BOTTLE (67877-429-05) 67877-429-10 1000 TABLET in 1 BOTTLE (67877-429-10) 67877-429-38 100 BLISTER PACK in 1 CARTON (67877-429-38) / 10 TABLET in 1 BLISTER PACK

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": "280c139f-c3a2-46e4-b990-ce3808166e86", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310433", "310434"], "spl_set_id": ["4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (67877-429-01)", "package_ndc": "67877-429-01", "marketing_start_date": "20151101"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (67877-429-05)", "package_ndc": "67877-429-05", "marketing_start_date": "20151101"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (67877-429-10)", "package_ndc": "67877-429-10", "marketing_start_date": "20151101"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (67877-429-38)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "67877-429-38", "marketing_start_date": "20151101"}], "brand_name": "Gabapentin", "product_id": "67877-429_280c139f-c3a2-46e4-b990-ce3808166e86", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "67877-429", "generic_name": "Gabapentin", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "800 mg/1"}], "application_number": "ANDA206402", "marketing_category": "ANDA", "marketing_start_date": "20151101", "listing_expiration_date": "20261231"}