FDA.reportPublic FDA data

Atomoxetine

Product NDC
64980-378
11-digit product format
649800378
Labeler code
64980
Product ID
64980-378_64643df1-f14e-4f1d-a422-9d7efc2995e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA079016
Marketing category
ANDA
Marketing start
2017-05-30
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
80 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 HYDROCHLORIDE80 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
64980-378-03Atomoxetine30 in 1 BOTTLECAPSULE3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-378-03EA - Each64980-37841e7e0b4-2a9a-4d64-b3be-c64826b65c6612017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-378ATOMOXETINE CAPSULE [RISING PHARMA HOLDINGS, INC.]10Current NDC, Legacy NDC, 1 package rows20250510_1cceab35-dc4a-40bc-a245-10b64820e217.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN1cceab35-dc4a-40bc-a245-10b64820e21711
608139atomoxetine HCl 100 MG Oral CapsulePSN1cceab35-dc4a-40bc-a245-10b64820e21711
349592atomoxetine HCl 18 MG Oral CapsulePSN1cceab35-dc4a-40bc-a245-10b64820e21711
349593atomoxetine HCl 25 MG Oral CapsulePSN1cceab35-dc4a-40bc-a245-10b64820e21711
349594atomoxetine HCl 40 MG Oral CapsulePSN1cceab35-dc4a-40bc-a245-10b64820e21711
349595atomoxetine HCl 60 MG Oral CapsulePSN1cceab35-dc4a-40bc-a245-10b64820e21711
608143atomoxetine HCl 80 MG Oral CapsulePSN1cceab35-dc4a-40bc-a245-10b64820e21711
349591atomoxetine 10 MG Oral CapsuleSCD1cceab35-dc4a-40bc-a245-10b64820e21711
608139atomoxetine 100 MG Oral CapsuleSCD1cceab35-dc4a-40bc-a245-10b64820e21711
349592atomoxetine 18 MG Oral CapsuleSCD1cceab35-dc4a-40bc-a245-10b64820e21711
349593atomoxetine 25 MG Oral CapsuleSCD1cceab35-dc4a-40bc-a245-10b64820e21711
349594atomoxetine 40 MG Oral CapsuleSCD1cceab35-dc4a-40bc-a245-10b64820e21711
349595atomoxetine 60 MG Oral CapsuleSCD1cceab35-dc4a-40bc-a245-10b64820e21711
608143atomoxetine 80 MG Oral CapsuleSCD1cceab35-dc4a-40bc-a245-10b64820e21711
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY1cceab35-dc4a-40bc-a245-10b64820e21711
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY1cceab35-dc4a-40bc-a245-10b64820e21711
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY1cceab35-dc4a-40bc-a245-10b64820e21711
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY1cceab35-dc4a-40bc-a245-10b64820e21711
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY1cceab35-dc4a-40bc-a245-10b64820e21711
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY1cceab35-dc4a-40bc-a245-10b64820e21711
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY1cceab35-dc4a-40bc-a245-10b64820e21711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-378-036498003780330 CAPSULE in 1 BOTTLE (64980-378-03) 30 capsule2017-05-300000-00-00NoNoCurrent