carglumic acid

Generic: carglumic acid

Labeler: burel pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carglumic acid
Generic Name carglumic acid
Labeler burel pharmaceuticals, llc
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

carglumic acid 200 mg/1

Manufacturer
Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-459
Product ID 35573-459_28393de7-fa10-4e7d-919e-4d0b19c888a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213395
Listing Expiration 2026-12-31
Marketing Start 2022-12-19

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 35573459
Hyphenated Format 35573-459

Supplemental Identifiers

RxCUI
905390
UPC
0335573459604
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 carglumic acid (source: ndc)
Generic Name carglumic acid (source: ndc)
Application Number ANDA213395 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET, FOR SUSPENSION in 1 BOTTLE (35573-459-60)
source: ndc

Packages (1)

35573-459-60 60 TABLET, FOR SUSPENSION in 1 BOTTLE (35573-459-60)

Ingredients (1)

carglumic acid (200 mg/1)

Linked Drug Pages (1)

Carglumic acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "28393de7-fa10-4e7d-919e-4d0b19c888a1", "openfda": {"nui": ["N0000184144", "N0000184143"], "upc": ["0335573459604"], "unii": ["5L0HB4V1EW"], "rxcui": ["905390"], "spl_set_id": ["2aee4281-402b-4cd6-9e6a-08945262e1a1"], "pharm_class_epc": ["Carbamoyl Phosphate Synthetase 1 Activator [EPC]"], "pharm_class_moa": ["Carbamoyl Phosphate Synthetase 1 Activators [MoA]"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FOR SUSPENSION in 1 BOTTLE (35573-459-60)", "package_ndc": "35573-459-60", "marketing_start_date": "20221219"}], "brand_name": "Carglumic acid", "product_id": "35573-459_28393de7-fa10-4e7d-919e-4d0b19c888a1", "dosage_form": "TABLET, FOR SUSPENSION", "pharm_class": ["Carbamoyl Phosphate Synthetase 1 Activator [EPC]", "Carbamoyl Phosphate Synthetase 1 Activators [MoA]"], "product_ndc": "35573-459", "generic_name": "Carglumic acid", "labeler_name": "Burel Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carglumic acid", "active_ingredients": [{"name": "CARGLUMIC ACID", "strength": "200 mg/1"}], "application_number": "ANDA213395", "marketing_category": "ANDA", "marketing_start_date": "20221219", "listing_expiration_date": "20261231"}