gabapentin

Generic: gabapentin

Labeler: medsource pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler medsource pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 100 mg/1

Manufacturer
Medsource Pharmaceuticals

Identifiers & Regulatory

Product NDC 45865-216
Product ID 45865-216_1277f18a-a854-3b06-e063-6294a90a88b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206943
Listing Expiration 2026-12-31
Marketing Start 2018-05-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45865216
Hyphenated Format 45865-216

Supplemental Identifiers

RxCUI
310430
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 ANDA206943 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (45865-216-30)
  • 120 CAPSULE in 1 BOTTLE (45865-216-51)
  • 60 CAPSULE in 1 BOTTLE (45865-216-60)
  • 90 CAPSULE in 1 BOTTLE (45865-216-90)
source: ndc

Packages (4)

45865-216-30 30 CAPSULE in 1 BOTTLE (45865-216-30) 45865-216-51 120 CAPSULE in 1 BOTTLE (45865-216-51) 45865-216-60 60 CAPSULE in 1 BOTTLE (45865-216-60) 45865-216-90 90 CAPSULE in 1 BOTTLE (45865-216-90)

Ingredients (1)

gabapentin (100 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": "1277f18a-a854-3b06-e063-6294a90a88b2", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "rxcui": ["310430"], "spl_set_id": ["1278512b-1493-db65-e063-6394a90ab161"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Medsource Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (45865-216-30)", "package_ndc": "45865-216-30", "marketing_start_date": "20220915"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (45865-216-51)", "package_ndc": "45865-216-51", "marketing_start_date": "20220602"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (45865-216-60)", "package_ndc": "45865-216-60", "marketing_start_date": "20240223"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (45865-216-90)", "package_ndc": "45865-216-90", "marketing_start_date": "20220613"}], "brand_name": "Gabapentin", "product_id": "45865-216_1277f18a-a854-3b06-e063-6294a90a88b2", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "45865-216", "generic_name": "Gabapentin", "labeler_name": "Medsource Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "100 mg/1"}], "application_number": "ANDA206943", "marketing_category": "ANDA", "marketing_start_date": "20180514", "listing_expiration_date": "20261231"}