FDA.reportPublic FDA data

atomoxetine

Product NDC
50090-7463
11-digit product format
500907463
Labeler code
50090
Product ID
50090-7463_2cc8f0a2-9b6a-4ddd-8fcb-2742cfbd13a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079019
Marketing category
ANDA
Marketing start
2017-05-30
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
100 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079019-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30
A079019-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30
A079019-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30
A079019-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30
A079019-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30
A079019-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30
A079019-007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A079019-001AB
A079019-002AB
A079019-003AB
A079019-004AB
A079019-005AB
A079019-006AB
A079019-007AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079019-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079019-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079019-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079019-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079019-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079019-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079019-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079019-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079019-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A079019-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A079019-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A079019-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A079019-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A079019-007AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
atomoxetineATOMOXETINEBryant Ranch Prepack97a4aa63-0877-40e5-94c4-ea487db5691d2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019
atomoxetineATOMOXETINEA-S Medication Solutions90f45a1e-f79f-468f-b21b-5dc82f5717aa2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019
ndc (product): 50090-7463
atomoxetineATOMOXETINENorthstar Rx LLC133a4b65-762b-4712-baba-2442546f03792026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019
atomoxetineATOMOXETINEGlenmark Pharmaceuticals Inc., USA0ab8d905-e890-4e91-a730-3e5d12f5c23f2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019
atomoxetineATOMOXETINEA-S Medication Solutionsf75bc8e2-8e8e-4883-be9c-b716842c52772024-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019
atomoxetineATOMOXETINEA-S Medication Solutions793928fb-fbcb-4fc6-90d4-f8a15e6b1f932024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019
atomoxetineATOMOXETINEA-S Medication Solutions47f6faeb-52b5-4b04-bf34-de5db8eb46dc2024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019

Additional Listing Data#

Finished product
Yes
Brand name base
atomoxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
57WVB6I2W0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
608139Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
90f45a1e-f79f-468f-b21b-5dc82f5717aaAvailable on FDA.report

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
50090-7463-0atomoxetine30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7463-0EA - Each50090-74632a809d6a-6033-4f23-bc64-b7d51de0800612024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7463ATOMOXETINE CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20241122_90f45a1e-f79f-468f-b21b-5dc82f5717aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
608139atomoxetine HCl 100 MG Oral CapsulePSN90f45a1e-f79f-468f-b21b-5dc82f5717aa4
608139atomoxetine 100 MG Oral CapsuleSCD90f45a1e-f79f-468f-b21b-5dc82f5717aa4
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY90f45a1e-f79f-468f-b21b-5dc82f5717aa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7463-05009074630030 CAPSULE in 1 BOTTLE (50090-7463-0) 30 capsule2024-11-19NoNoCurrent