carbaglu

Generic: carglumic acid

Labeler: recordati rare diseases
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbaglu
Generic Name carglumic acid
Labeler recordati rare diseases
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

carglumic acid 200 mg/1

Manufacturer
Recordati Rare Diseases

Identifiers & Regulatory

Product NDC 52276-312
Product ID 52276-312_7238020c-dcef-42ca-947b-6162e1488608
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022562
Listing Expiration 2026-12-31
Marketing Start 2010-03-18

Pharmacologic Class

Established (EPC)
carbamoyl phosphate synthetase 1 activator [epc]
Mechanism of Action
carbamoyl phosphate synthetase 1 activators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52276312
Hyphenated Format 52276-312

Supplemental Identifiers

RxCUI
905390 905394
UNII
5L0HB4V1EW
NUI
N0000184144 N0000184143

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 carbaglu (source: ndc)
Generic Name carglumic acid (source: ndc)
Application Number NDA022562 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 5 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-05)
  • 60 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-60)
source: ndc

Packages (2)

52276-312-05 5 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-05) 52276-312-60 60 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-60)

Ingredients (1)

carglumic acid (200 mg/1)

Linked Drug Pages (1)

Carbaglu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7238020c-dcef-42ca-947b-6162e1488608", "openfda": {"nui": ["N0000184144", "N0000184143"], "unii": ["5L0HB4V1EW"], "rxcui": ["905390", "905394"], "spl_set_id": ["10175e73-5172-4dde-a508-8a88b7afc0a1"], "pharm_class_epc": ["Carbamoyl Phosphate Synthetase 1 Activator [EPC]"], "pharm_class_moa": ["Carbamoyl Phosphate Synthetase 1 Activators [MoA]"], "manufacturer_name": ["Recordati Rare Diseases"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-05)", "package_ndc": "52276-312-05", "marketing_start_date": "20100318"}, {"sample": false, "description": "60 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-60)", "package_ndc": "52276-312-60", "marketing_start_date": "20100318"}], "brand_name": "Carbaglu", "product_id": "52276-312_7238020c-dcef-42ca-947b-6162e1488608", "dosage_form": "TABLET, FOR SUSPENSION", "pharm_class": ["Carbamoyl Phosphate Synthetase 1 Activator [EPC]", "Carbamoyl Phosphate Synthetase 1 Activators [MoA]"], "product_ndc": "52276-312", "generic_name": "Carglumic Acid", "labeler_name": "Recordati Rare Diseases", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbaglu", "active_ingredients": [{"name": "CARGLUMIC ACID", "strength": "200 mg/1"}], "application_number": "NDA022562", "marketing_category": "NDA", "marketing_start_date": "20100318", "listing_expiration_date": "20261231"}