Atomoxetine

Product NDC
71335-3033
11-digit product format
713353033
Labeler code
71335
Product ID
71335-3033_31f037c4-dd31-4f76-b1e8-b6126a3b7cd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079021
Marketing category
ANDA
Marketing start
2025-07-01
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake 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
Atomoxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57WVB6I2W0
Rxcui349594

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d16f546-db6a-1939-50fc-d06382424c97Product name420210903

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3033-1Atomoxetine30 in 1 BOTTLECAPSULE30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3033-1EA - Each71335-30336ba4f413-8e9a-4088-b3de-d94d3f6f6bde12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349594atomoxetine HCl 40 MG Oral CapsulePSNb00eb367-d7cc-42fa-91af-a1a5f90dbb41100
349594atomoxetine 40 MG Oral CapsuleSCDb00eb367-d7cc-42fa-91af-a1a5f90dbb41100
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSYb00eb367-d7cc-42fa-91af-a1a5f90dbb41100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3033-17133530330130 CAPSULE in 1 BOTTLE (71335-3033-1) 30 capsule2025-12-03NoNoHistorical