FDA.reportPublic FDA data

Atomoxetine

Product NDC
31722-718
11-digit product format
317220718
Labeler code
31722
Product ID
31722-718_52a3d33b-4b01-9de5-e063-6294a90ae28d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA202682
Marketing category
ANDA
Marketing start
2021-03-11
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
0d16f546-db6a-1939-50fc-d06382424c97Product name420210903

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-718-30Atomoxetine30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-718-30EA - Each31722-71840313913-2966-4670-97f1-8b327fc436a612021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-718ATOMOXETINE (ATOMOXETINE) CAPSULE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 1 package rows20210321_f266ab7b-5a68-42b5-b204-e3249bea0aed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
608139atomoxetine HCl 100 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
349592atomoxetine HCl 18 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
349593atomoxetine HCl 25 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
349594atomoxetine HCl 40 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
349595atomoxetine HCl 60 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
608143atomoxetine HCl 80 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
349591atomoxetine 10 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
608139atomoxetine 100 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
349592atomoxetine 18 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
349593atomoxetine 25 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
349594atomoxetine 40 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
349595atomoxetine 60 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
608143atomoxetine 80 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-718-303172207183030 CAPSULE in 1 BOTTLE (31722-718-30) 30 capsule2021-03-110000-00-00NoNoCurrent