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

Additional Listing Data#

Finished product
Yes
Brand name base
Atomoxetine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57WVB6I2W0
Rxcui2739831

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
0d16f546-db6a-1939-50fc-d06382424c97Product name420210903
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-456-01Atomoxetine hydrochloride1 in 1 CARTONSOLUTION11
72888-456-01Atomoxetine hydrochloride100 mL in 1 BOTTLE, GLASSSOLUTION1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2739831atomoxetine 4 MG/mL Oral SolutionPSN16096e9c-2dcd-4c84-a1a8-1c85d6d6898c1
2739831atomoxetine 4 MG/ML Oral SolutionSCD16096e9c-2dcd-4c84-a1a8-1c85d6d6898c1
2739831atomoxetine 4 MG (as atomoxetine hydrochloride 4.57 MG) per ML Oral SolutionSY16096e9c-2dcd-4c84-a1a8-1c85d6d6898c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72888-456-01728880456011 BOTTLE, GLASS in 1 CARTON (72888-456-01) / 100 mL in 1 BOTTLE, GLASS2026-03-20NoNoHistorical