FDA.reportPublic FDA data

Atomoxetine Hydrochloride

Product NDC
50268-057
11-digit product format
502680057
Labeler code
50268
Product ID
50268-057_47e225fb-3d2a-4f80-e063-6394a90aff85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA078983
Marketing category
ANDA
Marketing start
2020-02-13
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atomoxetine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE25 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
50268-057-11Atomoxetine Hydrochloride1 in 1 BLISTER PACKCAPSULE15
50268-057-13Atomoxetine Hydrochloride30 in 1 BOXCAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-057-11EA - Each50268-0573642f122-6abd-46d5-9232-7c123e835cf712020-03-10
50268-057-13EA - Each50268-057a138f520-ce73-4dc2-8c04-06adad1ace4912020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-057ATOMOXETINE HYDROCHLORIDE CAPSULE [AVPAK]4Current NDC, Legacy NDC, 2 package rows20240110_9e787cc2-5d0f-f231-e053-2a95a90ae99a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349593atomoxetine HCl 25 MG Oral CapsulePSN9e787cc2-5d0f-f231-e053-2a95a90ae99a5
349594atomoxetine HCl 40 MG Oral CapsulePSN9e787cc2-5d0f-f231-e053-2a95a90ae99a5
349593atomoxetine 25 MG Oral CapsuleSCD9e787cc2-5d0f-f231-e053-2a95a90ae99a5
349594atomoxetine 40 MG Oral CapsuleSCD9e787cc2-5d0f-f231-e053-2a95a90ae99a5
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY9e787cc2-5d0f-f231-e053-2a95a90ae99a5
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY9e787cc2-5d0f-f231-e053-2a95a90ae99a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-057-11502680057111 in 1 BLISTER PACKHistorical
50268-057-135026800571330 BLISTER PACK in 1 BOX (50268-057-13) / 1 CAPSULE in 1 BLISTER PACK (50268-057-11) 30 blister pack2020-02-130000-00-00NoNoCurrent