Atomoxetine

Product NDC
63629-9428
11-digit product format
636299428
Labeler code
63629
Product ID
63629-9428_b91d2f70-9d03-4d24-9efc-cd921643075f
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
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57WVB6I2W0
Rxcui349595

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
63629-9428-1Atomoxetine30 in 1 BOTTLECAPSULE30101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9428ATOMOXETINE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 1 package rows20231021_92de0ca1-6a02-4925-aefc-b32573d349a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349595atomoxetine HCl 60 MG Oral CapsulePSN92de0ca1-6a02-4925-aefc-b32573d349a7101
349595atomoxetine 60 MG Oral CapsuleSCD92de0ca1-6a02-4925-aefc-b32573d349a7101
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY92de0ca1-6a02-4925-aefc-b32573d349a7101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9428-16362994280130 CAPSULE in 1 BOTTLE (63629-9428-1) 30 capsule2022-08-230000-00-00NoNoCurrent