Atomoxetine

Product NDC
63629-9427
11-digit product format
636299427
Labeler code
63629
Product ID
63629-9427_42ef39aa-5c53-44e0-b9c9-4426104749f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090609
Marketing category
ANDA
Marketing start
2018-02-23
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
63629-9427-1Atomoxetine30 in 1 BOTTLECAPSULE30101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9427ATOMOXETINE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 1 package rows20231021_b7f78a37-d525-42b7-813a-fa3e18ae7b74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349594atomoxetine HCl 40 MG Oral CapsulePSNb7f78a37-d525-42b7-813a-fa3e18ae7b74101
349594atomoxetine 40 MG Oral CapsuleSCDb7f78a37-d525-42b7-813a-fa3e18ae7b74101
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSYb7f78a37-d525-42b7-813a-fa3e18ae7b74101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9427-16362994270130 CAPSULE in 1 BOTTLE (63629-9427-1) 30 capsule2022-08-230000-00-00NoNoCurrent