Home NDC 72888-456 Atomoxetine hydrochloride
Product NDC 72888-456
11-digit product format 728880456
Labeler code 72888
Product ID 72888-456_4e8dc87f-5d2d-5277-e063-6394a90ae95f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atomoxetine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Advagen Pharma Ltd.
Application NDA220320
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2026-03-20
Substance ATOMOXETINE HYDROCHLORIDE
Active strength 4 mg/mL
Pharmacologic classes Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake 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 1 .
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 N220320-001 ATONCY ATOMOXETINE HYDROCHLORIDE EQ 4MG BASE/ML SOLUTION / ORAL RLD, RS 2026-03-20
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 2026-08-01 22:54:32 2026-06 N220320-001 ATONCY EQ 4MG BASE/ML SOLUTION / ORAL RLD, RS 2026-03-20 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Atomoxetine hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATOMOXETINE HYDROCHLORIDE 4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57WVB6I2W0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2739831 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72888-456-01 Atomoxetine hydrochloride 1 in 1 CARTON SOLUTION 1 1 72888-456-01 Atomoxetine hydrochloride 100 mL in 1 BOTTLE, GLASS SOLUTION 100 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72888-456-01 72888045601 1 BOTTLE, GLASS in 1 CARTON (72888-456-01) / 100 mL in 1 BOTTLE, GLASS 2026-03-20 No No Current