gabapentin

Generic: gabapentin

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

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler asclemed usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 300 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-617
Product ID 76420-617_068d23f0-3994-f3d5-e063-6394a90ae9a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075360
Listing Expiration 2026-12-31
Marketing Start 2020-09-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420617
Hyphenated Format 76420-617

Supplemental Identifiers

RxCUI
310431
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 ANDA075360 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (76420-617-10)
  • 120 CAPSULE in 1 BOTTLE (76420-617-12)
  • 240 CAPSULE in 1 BOTTLE (76420-617-24)
  • 30 CAPSULE in 1 BOTTLE (76420-617-30)
  • 60 CAPSULE in 1 BOTTLE (76420-617-60)
  • 90 CAPSULE in 1 BOTTLE (76420-617-90)
source: ndc

Packages (6)

76420-617-10 100 CAPSULE in 1 BOTTLE (76420-617-10) 76420-617-12 120 CAPSULE in 1 BOTTLE (76420-617-12) 76420-617-24 240 CAPSULE in 1 BOTTLE (76420-617-24) 76420-617-30 30 CAPSULE in 1 BOTTLE (76420-617-30) 76420-617-60 60 CAPSULE in 1 BOTTLE (76420-617-60) 76420-617-90 90 CAPSULE in 1 BOTTLE (76420-617-90)

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": "068d23f0-3994-f3d5-e063-6394a90ae9a4", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310431"], "spl_set_id": ["5fb79774-c2d4-47ba-9a16-eb367d0fdcff"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (76420-617-10)", "package_ndc": "76420-617-10", "marketing_start_date": "20230930"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (76420-617-12)", "package_ndc": "76420-617-12", "marketing_start_date": "20230930"}, {"sample": false, "description": "240 CAPSULE in 1 BOTTLE (76420-617-24)", "package_ndc": "76420-617-24", "marketing_start_date": "20230930"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-617-30)", "package_ndc": "76420-617-30", "marketing_start_date": "20230930"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-617-60)", "package_ndc": "76420-617-60", "marketing_start_date": "20230930"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-617-90)", "package_ndc": "76420-617-90", "marketing_start_date": "20230930"}], "brand_name": "GABAPENTIN", "product_id": "76420-617_068d23f0-3994-f3d5-e063-6394a90ae9a4", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "76420-617", "generic_name": "GABAPENTIN", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GABAPENTIN", "active_ingredients": [{"name": "GABAPENTIN", "strength": "300 mg/1"}], "application_number": "ANDA075360", "marketing_category": "ANDA", "marketing_start_date": "20200907", "listing_expiration_date": "20261231"}