FDA.reportPublic FDA data

Atomoxetine Hydrochloride

Product NDC
51407-101
11-digit product format
514070101
Labeler code
51407
Product ID
51407-101_36399fad-3b5f-8994-e063-6394a90a523e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA078983
Marketing category
ANDA
Marketing start
2017-05-30
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
18 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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE18 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
51407-101-30Atomoxetine Hydrochloride30 in 1 BOTTLECAPSULE3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-101-30EA - Each51407-101910af2e6-8f7b-4d24-be8d-1ee6048a0cd812018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-101ATOMOXETINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]11Current NDC, Legacy NDC, 1 package rows20241213_6f14ced9-c16c-905a-e053-2a91aa0a031e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
608139atomoxetine HCl 100 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349592atomoxetine HCl 18 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349593atomoxetine HCl 25 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349594atomoxetine HCl 40 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349595atomoxetine HCl 60 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
608143atomoxetine HCl 80 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349591atomoxetine 10 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
608139atomoxetine 100 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349592atomoxetine 18 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349593atomoxetine 25 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349594atomoxetine 40 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349595atomoxetine 60 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
608143atomoxetine 80 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-101-305140701013030 CAPSULE in 1 BOTTLE (51407-101-30) 30 capsule2018-06-070000-00-00NoNoCurrent