FDA.reportPublic FDA data

Atomoxetine Hydrochloride

Product NDC
60505-2831
11-digit product format
605052831
Labeler code
60505
Product ID
60505-2831_ad1d5a70-74b7-c5db-b589-88081ba704f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA078983
Marketing category
ANDA
Marketing start
2018-05-21
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
18 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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE18 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
60505-2831-0Atomoxetine Hydrochloride10 in 1 CARTONCAPSULE1020
60505-2831-0Atomoxetine Hydrochloride10 in 1 BLISTER PACKCAPSULE1020
60505-2831-1Atomoxetine Hydrochloride100 in 1 BOTTLECAPSULE10020
60505-2831-3Atomoxetine Hydrochloride30 in 1 BOTTLECAPSULE3020
60505-2831-8Atomoxetine Hydrochloride1000 in 1 BOTTLECAPSULE100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2831-3EA - Each60505-2831e70d01c8-2a74-47d2-ab36-ea0fd5b64a9e12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2831ATOMOXETINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]20Current NDC, Legacy NDC, 5 package rows20250412_132852a6-5bff-15dd-255c-98309dd83630.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
608139atomoxetine HCl 100 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
349592atomoxetine HCl 18 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
349593atomoxetine HCl 25 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
349594atomoxetine HCl 40 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
349595atomoxetine HCl 60 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
608143atomoxetine HCl 80 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
349591atomoxetine 10 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
608139atomoxetine 100 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
349592atomoxetine 18 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
349593atomoxetine 25 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
349594atomoxetine 40 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
349595atomoxetine 60 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
608143atomoxetine 80 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
349591atomoxetine HCl 10 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
608139atomoxetine HCl 100 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349592atomoxetine HCl 18 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349593atomoxetine HCl 25 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349594atomoxetine HCl 40 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349595atomoxetine HCl 60 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
608143atomoxetine HCl 80 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349591atomoxetine 10 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
608139atomoxetine 100 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349592atomoxetine 18 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349593atomoxetine 25 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349594atomoxetine 40 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349595atomoxetine 60 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
608143atomoxetine 80 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-2831-06050528310010 BLISTER PACK in 1 CARTON (60505-2831-0) > 10 CAPSULE in 1 BLISTER PACK10 blister pack2018-05-210000-00-00NoNoCurrent
60505-2831-160505283101100 CAPSULE in 1 BOTTLE (60505-2831-1) 100 capsule2018-05-210000-00-00NoNoCurrent
60505-2831-36050528310330 CAPSULE in 1 BOTTLE (60505-2831-3) 30 capsule2018-05-210000-00-00NoNoCurrent
60505-2831-8605052831081000 CAPSULE in 1 BOTTLE (60505-2831-8) 1000 capsule2018-05-210000-00-00NoNoCurrent