FDA.reportPublic FDA data

Atomoxetine

Product NDC
50090-6143
Requested package NDC
50090-6143-0
11-digit product format
500906143
Labeler code
50090
Product ID
50090-6143_a726ffd7-e7bd-4005-8b8a-b4d9bb58b67f
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
40 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

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
A202682-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-03-11
A202682-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2021-03-11
A202682-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-03-11
A202682-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2021-03-11
A202682-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALABRS2021-03-11
A202682-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2021-03-11
A202682-007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-03-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202682-001AB
A202682-002AB
A202682-003AB
A202682-004AB
A202682-005AB
A202682-006AB
A202682-007AB

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 22:54:322026-06A202682-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-03-11a50c72e98297…
2026-08-01 22:54:322026-06A202682-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2021-03-11a50c72e98297…
2026-08-01 22:54:322026-06A202682-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-03-11a50c72e98297…
2026-08-01 22:54:322026-06A202682-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2021-03-11a50c72e98297…
2026-08-01 22:54:322026-06A202682-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALABRS2021-03-11a50c72e98297…
2026-08-01 22:54:322026-06A202682-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2021-03-11a50c72e98297…
2026-08-01 22:54:322026-06A202682-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-03-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202682-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202682-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202682-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A202682-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A202682-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A202682-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A202682-007AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtomoxetineATOMOXETINECamber Pharmaceuticals, Inc.f266ab7b-5a68-42b5-b204-e3249bea0aed2026-05-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202682
application number: ANDA202682
AtomoxetineATOMOXETINEA-S Medication Solutions652cb30f-4368-4009-93a3-3a0d2a365f422026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202682
application number: ANDA202682
AtomoxetineATOMOXETINENorthStar RxLLC14f2804d-2914-4dd9-86c0-d084fcfd7e502026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202682
application number: ANDA202682
AtomoxetineATOMOXETINEA-S Medication Solutions14fb8a4c-c2bf-4d44-bea9-cd159c2ca5fa2023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202682
application number: ANDA202682
AtomoxetineATOMOXETINEA-S Medication Solutions0782204e-56a3-4439-9fb8-194da94870492023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202682
application number: ANDA202682
ndc (package): 50090-6143-0
ndc (product): 50090-6143
ndc11 (package): 50090614300

Additional Listing Data#

Finished product
Yes
Brand name base
Atomoxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE40 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
349594Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0782204e-56a3-4439-9fb8-194da9487049Available 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
50090-6143-0Atomoxetine30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6143-0EA - Each50090-6143ecf72126-79be-4dab-8a96-08eeb3583ebe12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6143ATOMOXETINE (ATOMOXETINE) CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20231102_0782204e-56a3-4439-9fb8-194da9487049.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349594atomoxetine HCl 40 MG Oral CapsulePSN0782204e-56a3-4439-9fb8-194da94870493
349594atomoxetine 40 MG Oral CapsuleSCD0782204e-56a3-4439-9fb8-194da94870493
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY0782204e-56a3-4439-9fb8-194da94870493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6143-05009061430030 CAPSULE in 1 BOTTLE (50090-6143-0) 30 capsule2022-10-040000-00-00NoNoCurrent