FDA.reportPublic FDA data

atomoxetine

Product NDC
68382-223
11-digit product format
683820223
Labeler code
68382
Product ID
68382-223_ffa27721-74b3-4ad8-b4c3-8aa29c67861c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA079017
Marketing category
ANDA
Marketing start
2017-12-06
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
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
68382-223-02atomoxetine2000 in 1 BOTTLECAPSULE20006
68382-223-06atomoxetine30 in 1 BOTTLECAPSULE306
68382-223-10atomoxetine1000 in 1 BOTTLECAPSULE10006
68382-223-14atomoxetine60 in 1 BOTTLECAPSULE606
68382-223-16atomoxetine90 in 1 BOTTLECAPSULE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-223ATOMOXETINE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]6Legacy NDC, 5 package rows20250326_5f89c7c9-4c25-4ba2-ad90-5aeadb48f214.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608139atomoxetine HCl 100 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349592atomoxetine HCl 18 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349593atomoxetine HCl 25 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349594atomoxetine HCl 40 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349595atomoxetine HCl 60 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608143atomoxetine HCl 80 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349591atomoxetine 10 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608139atomoxetine 100 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349592atomoxetine 18 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349593atomoxetine 25 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349594atomoxetine 40 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349595atomoxetine 60 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608143atomoxetine 80 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-223-02683820223022000 CAPSULE in 1 BOTTLE (68382-223-02) 2000 capsule2017-12-060000-00-00NoNoCurrent
68382-223-066838202230630 CAPSULE in 1 BOTTLE (68382-223-06) 30 capsule2017-12-060000-00-00NoNoCurrent
68382-223-10683820223101000 CAPSULE in 1 BOTTLE (68382-223-10) 1000 capsule2017-12-060000-00-00NoNoCurrent
68382-223-146838202231460 CAPSULE in 1 BOTTLE (68382-223-14) 60 capsule2017-12-060000-00-00NoNoCurrent
68382-223-166838202231690 CAPSULE in 1 BOTTLE (68382-223-16) 90 capsule2017-12-060000-00-00NoNoCurrent