FDA.reportPublic FDA data

AQNEURSA

Product NDC
83853-101
11-digit product format
838530101
Labeler code
83853
Product ID
83853-101_49d32782-3faa-4670-99bf-db9b7115f2d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levacetylleucine
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
IntraBio Inc
Application
NDA219132
Marketing category
NDA
Marketing start
2024-09-24
Substance
LEVACETYLLEUCINE
Active strength
1000 mg/1
Pharmacologic classes
Bile Salt Export Pump Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AQNEURSA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVACETYLLEUCINE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE915HL7K2O
Rxcui2693617, 2693623

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26bf4a65-f9d3-42c3-9d3b-ab4f3a6600d5Product name120250401

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83853-101-01AQNEURSA1 in 1 PACKETGRANULE, FOR SUSPENSION15
83853-101-01AQNEURSA28 in 1 CARTONGRANULE, FOR SUSPENSION285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83853-101-01EA - Each83853-10102871b33-e854-4993-af27-4112cf575be012024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83853-101AQNEURSA (LEVACETYLLEUCINE) GRANULE, FOR SUSPENSION [INTRABIO INC]5Current NDC, 2 package rows20250125_0f248e55-d1bb-13f9-e063-6294a90a05ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2693623AQNEURSA 1 GM Granules for Oral SuspensionPSN0f248e55-d1bb-13f9-e063-6294a90a05ce5
2693617levacetylleucine 1 GM Granules for Oral SuspensionPSN0f248e55-d1bb-13f9-e063-6294a90a05ce5
2693623levacetylleucine 1000 MG Granules for Oral Suspension [Aqneursa]SBD0f248e55-d1bb-13f9-e063-6294a90a05ce5
2693617levacetylleucine 1000 MG Granules for Oral SuspensionSCD0f248e55-d1bb-13f9-e063-6294a90a05ce5
2693623Aqneursa 1 GM Granules for Oral SuspensionSY0f248e55-d1bb-13f9-e063-6294a90a05ce5
2693623Aqneursa 1000 MG Granules for Oral SuspensionSY0f248e55-d1bb-13f9-e063-6294a90a05ce5
2693617levacetylleucine 1 GM Granules for Oral SuspensionSY0f248e55-d1bb-13f9-e063-6294a90a05ce5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83853-101-018385301010128 PACKET in 1 CARTON (83853-101-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET28 packet2024-09-24NoNoCurrent