gabapentin

Generic: gabapentin

Labeler: mullan pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler mullan pharmaceutical inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

gabapentin 100 mg/1

Manufacturer
Mullan Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 83301-0003
Product ID 83301-0003_3ce59317-9cf6-5ae5-e063-6394a90aba6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075477
Listing Expiration 2026-12-31
Marketing Start 2023-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 833010003
Hyphenated Format 83301-0003

Supplemental Identifiers

RxCUI
310430 310431 310432
UPC
0383301000437 0383301000338 0383301000413 0383301000314 0383301000512 0383301000529 0383301000321 0383301000420
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 ANDA075477 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (83301-0003-1)
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (83301-0003-2)
  • 1000 CAPSULE in 1 BOTTLE, PLASTIC (83301-0003-3)
source: ndc

Packages (3)

83301-0003-1 100 CAPSULE in 1 BOTTLE, PLASTIC (83301-0003-1) 83301-0003-2 500 CAPSULE in 1 BOTTLE, PLASTIC (83301-0003-2) 83301-0003-3 1000 CAPSULE in 1 BOTTLE, PLASTIC (83301-0003-3)

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": "3ce59317-9cf6-5ae5-e063-6394a90aba6c", "openfda": {"nui": ["N0000008486"], "upc": ["0383301000437", "0383301000338", "0383301000413", "0383301000314", "0383301000512", "0383301000529", "0383301000321", "0383301000420"], "unii": ["6CW7F3G59X"], "rxcui": ["310430", "310431", "310432"], "spl_set_id": ["74474aa4-4859-42d2-92d8-f23f18b34e04"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Mullan Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (83301-0003-1)", "package_ndc": "83301-0003-1", "marketing_start_date": "20230501"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (83301-0003-2)", "package_ndc": "83301-0003-2", "marketing_start_date": "20230501"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE, PLASTIC (83301-0003-3)", "package_ndc": "83301-0003-3", "marketing_start_date": "20230501"}], "brand_name": "Gabapentin", "product_id": "83301-0003_3ce59317-9cf6-5ae5-e063-6394a90aba6c", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "83301-0003", "generic_name": "Gabapentin", "labeler_name": "Mullan Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "100 mg/1"}], "application_number": "ANDA075477", "marketing_category": "ANDA", "marketing_start_date": "20230501", "listing_expiration_date": "20261231"}