Atomoxetine

Product NDC
0904-6908
11-digit product format
009046908
Labeler code
0904
Product ID
0904-6908_e4c4122b-6772-46a0-aaaa-3815e6a9736f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
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
0904-6908-04Atomoxetine30 in 1 CARTONCAPSULE305
0904-6908-04Atomoxetine1 in 1 BLISTER PACKCAPSULE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6908-04EA - Each0904-6908ba3734b2-c3eb-4c7a-a818-f4207c66768d12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6908ATOMOXETINE CAPSULE [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20250330_f98c3424-1c43-43e4-8bca-2e3430f50c63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349594atomoxetine HCl 40 MG Oral CapsulePSNf98c3424-1c43-43e4-8bca-2e3430f50c635
349594atomoxetine 40 MG Oral CapsuleSCDf98c3424-1c43-43e4-8bca-2e3430f50c635
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSYf98c3424-1c43-43e4-8bca-2e3430f50c635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6908-040090469080430 BLISTER PACK in 1 CARTON (0904-6908-04) / 1 CAPSULE in 1 BLISTER PACK30 blister pack2018-02-230000-00-00NoNoCurrent