FDA.reportPublic FDA data

Atomoxetine

Product NDC
60687-326
11-digit product format
606870326
Labeler code
60687
Product ID
60687-326_2759be5a-a8a1-2119-e063-6394a90a38ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA079016
Marketing category
ANDA
Marketing start
2017-09-08
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
Rxcui349593, 349594

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
60687-326-25Atomoxetine30 in 1 BOX, UNIT-DOSECAPSULE307
60687-326-95Atomoxetine1 in 1 BLISTER PACKCAPSULE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-326-25EA - Each60687-32616595cea-27f6-4d49-812f-0db367349b2a12017-10-13
60687-326-95EA - Each60687-3264c9ed5e0-8063-447d-bf29-956ff050479d12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-326ATOMOXETINE CAPSULE [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20241122_10d36b32-0202-4c03-8a1a-cd5d53f231e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349593atomoxetine HCl 25 MG Oral CapsulePSN10d36b32-0202-4c03-8a1a-cd5d53f231e77
349594atomoxetine HCl 40 MG Oral CapsulePSN10d36b32-0202-4c03-8a1a-cd5d53f231e77
349593atomoxetine 25 MG Oral CapsuleSCD10d36b32-0202-4c03-8a1a-cd5d53f231e77
349594atomoxetine 40 MG Oral CapsuleSCD10d36b32-0202-4c03-8a1a-cd5d53f231e77
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY10d36b32-0202-4c03-8a1a-cd5d53f231e77
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY10d36b32-0202-4c03-8a1a-cd5d53f231e77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-326-256068703262530 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-326-25) / 1 CAPSULE in 1 BLISTER PACK (60687-326-95) 30 blister pack2017-09-080000-00-00NoNoCurrent
60687-326-95606870326951 in 1 BLISTER PACKHistorical