FDA.reportPublic FDA data

atomoxetine

Product NDC
68462-269
11-digit product format
684620269
Labeler code
68462
Product ID
68462-269_041a1f90-59cd-4a30-9519-a37853af7239
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA079019
Marketing category
ANDA
Marketing start
2017-05-30
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
0d16f546-db6a-1939-50fc-d06382424c97Product name420210903
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-269-23atomoxetine2000 in 1 BOTTLECAPSULE20007
68462-269-30atomoxetine30 in 1 BOTTLECAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-269-30EA - Each68462-2695295935f-ec36-424a-ba5e-01b7385ffe5c12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-269ATOMOXETINE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]6Current NDC, Legacy NDC, 2 package rows20230615_0ab8d905-e890-4e91-a730-3e5d12f5c23f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN0ab8d905-e890-4e91-a730-3e5d12f5c23f7
608139atomoxetine HCl 100 MG Oral CapsulePSN0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349592atomoxetine HCl 18 MG Oral CapsulePSN0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349593atomoxetine HCl 25 MG Oral CapsulePSN0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349594atomoxetine HCl 40 MG Oral CapsulePSN0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349595atomoxetine HCl 60 MG Oral CapsulePSN0ab8d905-e890-4e91-a730-3e5d12f5c23f7
608143atomoxetine HCl 80 MG Oral CapsulePSN0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349591atomoxetine 10 MG Oral CapsuleSCD0ab8d905-e890-4e91-a730-3e5d12f5c23f7
608139atomoxetine 100 MG Oral CapsuleSCD0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349592atomoxetine 18 MG Oral CapsuleSCD0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349593atomoxetine 25 MG Oral CapsuleSCD0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349594atomoxetine 40 MG Oral CapsuleSCD0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349595atomoxetine 60 MG Oral CapsuleSCD0ab8d905-e890-4e91-a730-3e5d12f5c23f7
608143atomoxetine 80 MG Oral CapsuleSCD0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY0ab8d905-e890-4e91-a730-3e5d12f5c23f7
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY0ab8d905-e890-4e91-a730-3e5d12f5c23f7
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY0ab8d905-e890-4e91-a730-3e5d12f5c23f7
349595atomoxetine HCl 60 MG Oral CapsulePSN97a4aa63-0877-40e5-94c4-ea487db5691d2
349595atomoxetine 60 MG Oral CapsuleSCD97a4aa63-0877-40e5-94c4-ea487db5691d2
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY97a4aa63-0877-40e5-94c4-ea487db5691d2
349595atomoxetine HCl 60 MG Oral CapsulePSN793928fb-fbcb-4fc6-90d4-f8a15e6b1f931
349595atomoxetine 60 MG Oral CapsuleSCD793928fb-fbcb-4fc6-90d4-f8a15e6b1f931
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY793928fb-fbcb-4fc6-90d4-f8a15e6b1f931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-269-23684620269232000 CAPSULE in 1 BOTTLE (68462-269-23) 2000 capsule2017-05-300000-00-00NoNoCurrent
68462-269-306846202693030 CAPSULE in 1 BOTTLE (68462-269-30) 30 capsule2017-05-300000-00-00NoNoCurrent