Home NDC 83853-101-01 AQNEURSA
Product NDC 83853-101
Requested package NDC 83853-101-01
11-digit product format 838530101
Labeler code 83853
Product ID 83853-101_c94eb0a9-2978-4fa6-9bc2-e02f7da94768
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219132-001 AQNEURSA LEVACETYLLEUCINE 1GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2024-09-24
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219132-001 11400067 2037-04-19 U-4170 2025-04-22 N219132-001 12433862 2037-04-19 U-4284 2025-10-22 N219132-001 12433863 2037-04-19 U-4285 2025-10-22
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219132-001 NCE 2029-09-24 N219132-001 ODE-498 2031-09-24
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N219132-001 AQNEURSA 1GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2024-09-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219132-001 AQNEURSA 1GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2024-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219132-001 AQNEURSA 1GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2024-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219132-001 AQNEURSA 1GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2024-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219132-001 AQNEURSA 1GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2024-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219132-001 AQNEURSA 1GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2024-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219132-001 AQNEURSA 1GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2024-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N219132-001 AQNEURSA 1GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2024-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N219132-001 AQNEURSA 1GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2024-09-24 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N219132-001 AQNEURSA 1GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2024-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N219132-001 AQNEURSA 1GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2024-09-24 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219132-001 AQNEURSA 1GM/PACKET FOR SUSPENSION / ORAL RLD, RS 2024-09-24 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N219132-001 11400067 2037-04-19 U-4170 2025-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219132-001 12433862 2037-04-19 U-4284 2025-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219132-001 12433863 2037-04-19 U-4285 2025-10-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219132-001 11400067 2037-04-19 U-4170 2025-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219132-001 12433862 2037-04-19 U-4284 2025-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219132-001 12433863 2037-04-19 U-4285 2025-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219132-001 11400067 2037-04-19 U-4170 2025-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219132-001 12433862 2037-04-19 U-4284 2025-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219132-001 12433863 2037-04-19 U-4285 2025-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219132-001 11400067 2037-04-19 U-4170 2025-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219132-001 12433862 2037-04-19 U-4284 2025-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219132-001 12433863 2037-04-19 U-4285 2025-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219132-001 11400067 2037-08-11 U-4170 2025-04-22 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219132-001 11400067 2037-04-19 U-4170 2025-04-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219132-001 12433862 2037-04-19 U-4284 2025-10-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219132-001 12433863 2037-04-19 U-4285 2025-10-22 a50c72e98297…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base AQNEURSA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVACETYLLEUCINE 1000 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83853-101-01 AQNEURSA 1 in 1 PACKET GRANULE, FOR SUSPENSION 1 5 83853-101-01 AQNEURSA 28 in 1 CARTON GRANULE, FOR SUSPENSION 28 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83853-101 AQNEURSA (LEVACETYLLEUCINE) GRANULE, FOR SUSPENSION [INTRABIO INC] 5 Current NDC, 2 package rows 20250125_0f248e55-d1bb-13f9-e063-6294a90a05ce.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83853-101-01 83853010101 28 PACKET in 1 CARTON (83853-101-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET 28 packet 2024-09-24 No No Current