FDA.reportPublic FDA data

atomoxetine

Product NDC
68382-218
11-digit product format
683820218
Labeler code
68382
Product ID
68382-218_8e543a65-7611-4362-94ba-0b3f929c776c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA079017
Marketing category
ANDA
Marketing start
2017-06-12
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
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
68382-218-02atomoxetine2000 in 1 BOTTLECAPSULE20006
68382-218-06atomoxetine30 in 1 BOTTLECAPSULE306
68382-218-10atomoxetine1000 in 1 BOTTLECAPSULE10006
68382-218-14atomoxetine60 in 1 BOTTLECAPSULE606
68382-218-16atomoxetine90 in 1 BOTTLECAPSULE906
68382-218-30atomoxetine10 in 1 BLISTER PACKCAPSULE106
68382-218-77atomoxetine10 in 1 CARTONCAPSULE106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-218ATOMOXETINE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 7 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
68382-218-02683820218022000 CAPSULE in 1 BOTTLE (68382-218-02) 2000 capsule2017-06-120000-00-00NoNoCurrent
68382-218-066838202180630 CAPSULE in 1 BOTTLE (68382-218-06) 30 capsule2017-06-120000-00-00NoNoCurrent
68382-218-10683820218101000 CAPSULE in 1 BOTTLE (68382-218-10) 1000 capsule2017-06-120000-00-00NoNoCurrent
68382-218-146838202181460 CAPSULE in 1 BOTTLE (68382-218-14) 60 capsule2017-06-120000-00-00NoNoCurrent
68382-218-166838202181690 CAPSULE in 1 BOTTLE (68382-218-16) 90 capsule2017-06-120000-00-00NoNoCurrent
68382-218-306838202183010 in 1 BLISTER PACKHistorical
68382-218-776838202187710 BLISTER PACK in 1 CARTON (68382-218-77) / 10 CAPSULE in 1 BLISTER PACK (68382-218-30) 10 blister pack2017-06-120000-00-00NoNoCurrent