FDA.reportPublic FDA data

Atomoxetine Hydrochloride

Product NDC
50090-4236
11-digit product format
500904236
Labeler code
50090
Product ID
50090-4236_d1a130e7-3cee-40cf-a4c6-cb3893304987
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078983
Marketing category
ANDA
Marketing start
2018-05-21
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 Hydrochloride
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4236-02023-02-07C16284748780-1f386c649-b91b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATOMOXETINE CAPSULES safely and effectively. See full prescribing information for ATOMOXETINE CAPSULES . ATOMOXETINE capsules, for oral use Initial U.S. Approval: 2002
50090-4236-02023-01-30C16284748780-1f386c649-b91b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATOMOXETINE CAPSULES safely and effectively. See full prescribing information for ATOMOXETINE CAPSULES . ATOMOXETINE capsules, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4236-0Atomoxetine Hydrochloride30 in 1 BOTTLECAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4236-0EA - Each50090-4236b7b5525e-3cd7-47db-ab89-d151d8f6904b12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4236ATOMOXETINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 1 package rows20230208_19b10860-aa08-4480-816c-c207819e5f9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349594atomoxetine HCl 40 MG Oral CapsulePSN19b10860-aa08-4480-816c-c207819e5f9e7
349594atomoxetine 40 MG Oral CapsuleSCD19b10860-aa08-4480-816c-c207819e5f9e7
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY19b10860-aa08-4480-816c-c207819e5f9e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4236-05009042360030 CAPSULE in 1 BOTTLE (50090-4236-0) 30 capsule2019-03-290000-00-00NoNoCurrent