Atomoxetine

Product NDC
50090-6127
11-digit product format
500906127
Labeler code
50090
Product ID
50090-6127_d1b894c8-903c-4edc-b02a-d2c34528d217
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202682
Marketing category
ANDA
Marketing start
2021-03-11
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
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 HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57WVB6I2W0
Rxcui608143

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
50090-6127-0Atomoxetine30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6127-0EA - Each50090-61277cb07afc-acb6-4d5d-aed4-cdf4bf26217012022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6127ATOMOXETINE (ATOMOXETINE) CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20231103_652cb30f-4368-4009-93a3-3a0d2a365f42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
608143atomoxetine HCl 80 MG Oral CapsulePSN652cb30f-4368-4009-93a3-3a0d2a365f425
608143atomoxetine 80 MG Oral CapsuleSCD652cb30f-4368-4009-93a3-3a0d2a365f425
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY652cb30f-4368-4009-93a3-3a0d2a365f425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6127-05009061270030 CAPSULE in 1 BOTTLE (50090-6127-0) 30 capsule2022-10-030000-00-00NoNoCurrent