FDA.reportPublic FDA data

Atomoxetine hydrochloride

Product NDC
0781-2266
11-digit product format
007812266
Labeler code
0781
Product ID
0781-2266_6b194d5b-7326-4baf-9e5a-d9ada2f369ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA079018
Marketing category
ANDA
Marketing start
2010-12-15
Marketing end
0000-00-00
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0781-2266-31IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0781-2266-22IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0781-2266-31IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0781-2266-22IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0781-2266-22EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0781-2266-31EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0781-2266-222020-01-31C16284748780-19d75b9cf-f524-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Atomoxetine Hydrochloride Capsules safely and effectively. See full prescribing information for Atomoxetine Hydrochloride Capsules Initial U.S. Approval: 2002
0781-2266-312020-01-31C16284748780-19d75b9cf-f524-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Atomoxetine Hydrochloride Capsules safely and effectively. See full prescribing information for Atomoxetine Hydrochloride Capsules Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-2266-22Atomoxetine hydrochloride2000 in 1 BOTTLECAPSULE20004
0781-2266-31Atomoxetine hydrochloride30 in 1 BOTTLECAPSULE304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATOMOXETINE HYDROCHLORIDEACTIVE INGREDIENT57WVB6I2W0ATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4
ATOMOXETINEACTIVE MOIETYASW034S0B8ATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4
GELATININACTIVE INGREDIENT2G86QN327LATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4
SHELLACINACTIVE INGREDIENT46N107B71OATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-2266ATOMOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC]4Legacy NDC, 2 package rows20110111_47137273-b9c1-4cb4-99ca-2dab9690b560.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN47137273-b9c1-4cb4-99ca-2dab9690b5604
608139atomoxetine HCl 100 MG Oral CapsulePSN47137273-b9c1-4cb4-99ca-2dab9690b5604
349592atomoxetine HCl 18 MG Oral CapsulePSN47137273-b9c1-4cb4-99ca-2dab9690b5604
349593atomoxetine HCl 25 MG Oral CapsulePSN47137273-b9c1-4cb4-99ca-2dab9690b5604
349594atomoxetine HCl 40 MG Oral CapsulePSN47137273-b9c1-4cb4-99ca-2dab9690b5604
349595atomoxetine HCl 60 MG Oral CapsulePSN47137273-b9c1-4cb4-99ca-2dab9690b5604
608143atomoxetine HCl 80 MG Oral CapsulePSN47137273-b9c1-4cb4-99ca-2dab9690b5604
349591atomoxetine 10 MG Oral CapsuleSCD47137273-b9c1-4cb4-99ca-2dab9690b5604
608139atomoxetine 100 MG Oral CapsuleSCD47137273-b9c1-4cb4-99ca-2dab9690b5604
349592atomoxetine 18 MG Oral CapsuleSCD47137273-b9c1-4cb4-99ca-2dab9690b5604
349593atomoxetine 25 MG Oral CapsuleSCD47137273-b9c1-4cb4-99ca-2dab9690b5604
349594atomoxetine 40 MG Oral CapsuleSCD47137273-b9c1-4cb4-99ca-2dab9690b5604
349595atomoxetine 60 MG Oral CapsuleSCD47137273-b9c1-4cb4-99ca-2dab9690b5604
608143atomoxetine 80 MG Oral CapsuleSCD47137273-b9c1-4cb4-99ca-2dab9690b5604
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY47137273-b9c1-4cb4-99ca-2dab9690b5604
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY47137273-b9c1-4cb4-99ca-2dab9690b5604
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY47137273-b9c1-4cb4-99ca-2dab9690b5604
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY47137273-b9c1-4cb4-99ca-2dab9690b5604
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY47137273-b9c1-4cb4-99ca-2dab9690b5604
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY47137273-b9c1-4cb4-99ca-2dab9690b5604
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY47137273-b9c1-4cb4-99ca-2dab9690b5604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0781-2266-22007812266222000 in 1 BOTTLEHistorical
0781-2266-310078122663130 in 1 BOTTLEHistorical