FDA.reportPublic FDA data

atomoxetine

Product NDC
16714-760
11-digit product format
167140760
Labeler code
16714
Product ID
16714-760_35db9ce2-5084-4b5f-8bac-63915457cccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA079019
Marketing category
ANDA
Marketing start
2018-06-01
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
80 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57WVB6I2W0
Rxcui349591, 349592, 349593, 349594, 349595, 608139, 608143

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
16714-760-01atomoxetine30 in 1 BOTTLECAPSULE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-760-01EA - Each16714-76072666cc3-cabd-401a-aac4-8ebb2858c1ac12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-760ATOMOXETINE CAPSULE [NORTHSTAR RX LLC]5Current NDC, Legacy NDC, 1 package rows20230919_133a4b65-762b-4712-baba-2442546f0379.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
608139atomoxetine HCl 100 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
349592atomoxetine HCl 18 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
349593atomoxetine HCl 25 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
349594atomoxetine HCl 40 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
349595atomoxetine HCl 60 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
608143atomoxetine HCl 80 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
349591atomoxetine 10 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
608139atomoxetine 100 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
349592atomoxetine 18 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
349593atomoxetine 25 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
349594atomoxetine 40 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
349595atomoxetine 60 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
608143atomoxetine 80 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-760-011671407600130 CAPSULE in 1 BOTTLE (16714-760-01) 30 capsule2018-06-010000-00-00NoNoCurrent