Atomoxetine

Product NDC
50090-6512
11-digit product format
500906512
Labeler code
50090
Product ID
50090-6512_1f10d97d-94f3-4f0a-8332-df2d5fb95b0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079022
Marketing category
ANDA
Marketing start
2017-05-30
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57WVB6I2W0
Rxcui349593

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
50090-6512-0Atomoxetine30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6512-0EA - Each50090-6512fabd658e-eb79-4083-903e-3ead2000b90c12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6512ATOMOXETINE CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20230608_402711d7-bd44-4f2a-ad2b-4756cdc68645.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349593atomoxetine HCl 25 MG Oral CapsulePSN402711d7-bd44-4f2a-ad2b-4756cdc686451
349593atomoxetine 25 MG Oral CapsuleSCD402711d7-bd44-4f2a-ad2b-4756cdc686451
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY402711d7-bd44-4f2a-ad2b-4756cdc686451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6512-05009065120030 CAPSULE in 1 BOTTLE (50090-6512-0) 30 capsule2023-06-01NoNoCurrent