gralise

Generic: gabapentin

Labeler: almatica pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gralise
Generic Name gabapentin
Labeler almatica pharma llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

gabapentin 450 mg/1

Manufacturer
Almatica Pharma LLC

Identifiers & Regulatory

Product NDC 52427-804
Product ID 52427-804_44a61305-2313-59c4-8a44-98c827461735
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022544
Listing Expiration 2026-12-31
Marketing Start 2023-12-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52427804
Hyphenated Format 52427-804

Supplemental Identifiers

RxCUI
1115012 1115013 1806380 1806382 2398511 2398512 2634743 2634745 2634747 2634749 2634751 2634753
UPC
0352427850608 0352427803901 0352427806902 0352427890604 0352427804601
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 gralise (source: ndc)
Generic Name gabapentin (source: ndc)
Application Number NDA022544 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (52427-804-60)
source: ndc

Packages (1)

52427-804-60 60 TABLET, FILM COATED in 1 BOTTLE (52427-804-60)

Ingredients (1)

gabapentin (450 mg/1)

Linked Drug Pages (1)

Gralise ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44a61305-2313-59c4-8a44-98c827461735", "openfda": {"nui": ["N0000008486"], "upc": ["0352427850608", "0352427803901", "0352427806902", "0352427890604", "0352427804601"], "unii": ["6CW7F3G59X"], "rxcui": ["1115012", "1115013", "1806380", "1806382", "2398511", "2398512", "2634743", "2634745", "2634747", "2634749", "2634751", "2634753"], "spl_set_id": ["466273b1-c9fc-3930-c94b-aa11394d5140"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Almatica Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (52427-804-60)", "package_ndc": "52427-804-60", "marketing_start_date": "20231231"}], "brand_name": "Gralise", "product_id": "52427-804_44a61305-2313-59c4-8a44-98c827461735", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "52427-804", "generic_name": "gabapentin", "labeler_name": "Almatica Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gralise", "active_ingredients": [{"name": "GABAPENTIN", "strength": "450 mg/1"}], "application_number": "NDA022544", "marketing_category": "NDA", "marketing_start_date": "20231231", "listing_expiration_date": "20261231"}