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 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 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 2026-09-14 22:38:34 2026-08 N220320-001 ATONCY EQ 4MG BASE/ML SOLUTION / ORAL RLD, RS 2026-03-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220320-001 ATONCY EQ 4MG BASE/ML SOLUTION / ORAL RLD, RS 2026-03-20 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220320-001 ATONCY EQ 4MG BASE/ML SOLUTION / ORAL RLD, RS 2026-03-20 a50c72e98297…
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 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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