FDA.reportPublic FDA data

Atomoxetine

Product NDC
63629-9427
11-digit product format
636299427
Labeler code
63629
Product ID
63629-9427_42ef39aa-5c53-44e0-b9c9-4426104749f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090609
Marketing category
ANDA
Marketing start
2018-02-23
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
A090609-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2018-02-23
A090609-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2018-02-23
A090609-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2018-02-23
A090609-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2018-02-23
A090609-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2018-02-23
A090609-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2018-02-23
A090609-007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2018-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090609-001AB
A090609-002AB
A090609-003AB
A090609-004AB
A090609-005AB
A090609-006AB
A090609-007AB

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 22:54:322026-06A090609-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2018-02-23a50c72e98297…
2026-08-01 22:54:322026-06A090609-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2018-02-23a50c72e98297…
2026-08-01 22:54:322026-06A090609-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2018-02-23a50c72e98297…
2026-08-01 22:54:322026-06A090609-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2018-02-23a50c72e98297…
2026-08-01 22:54:322026-06A090609-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2018-02-23a50c72e98297…
2026-08-01 22:54:322026-06A090609-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2018-02-23a50c72e98297…
2026-08-01 22:54:322026-06A090609-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2018-02-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090609-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090609-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A090609-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A090609-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A090609-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A090609-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A090609-007AB1a50c72e98297…

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
AtomoxetineATOMOXETINEREMEDYREPACK INC.d7002d75-edad-4141-91bf-7eebf50ad1aa2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090609
application number: ANDA090609
AtomoxetineATOMOXETINEMajor Pharmaceuticalsf98c3424-1c43-43e4-8bca-2e3430f50c632025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090609
application number: ANDA090609
AtomoxetineATOMOXETINEBryant Ranch Prepackb7f78a37-d525-42b7-813a-fa3e18ae7b742023-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090609
application number: ANDA090609
ndc (product): 63629-9427
AtomoxetineATOMOXETINEBryant Ranch Prepack92de0ca1-6a02-4925-aefc-b32573d349a72023-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090609
application number: ANDA090609
AtomoxetineATOMOXETINEDr. Reddy's Laboratories Limited973bdc9b-6421-7e00-e2b6-3cce036d363e2022-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090609
application number: ANDA090609

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
b7f78a37-d525-42b7-813a-fa3e18ae7b74Available 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
63629-9427-1Atomoxetine30 in 1 BOTTLECAPSULE30101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9427ATOMOXETINE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 1 package rows20231021_b7f78a37-d525-42b7-813a-fa3e18ae7b74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349594atomoxetine HCl 40 MG Oral CapsulePSNb7f78a37-d525-42b7-813a-fa3e18ae7b74101
349594atomoxetine 40 MG Oral CapsuleSCDb7f78a37-d525-42b7-813a-fa3e18ae7b74101
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSYb7f78a37-d525-42b7-813a-fa3e18ae7b74101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9427-16362994270130 CAPSULE in 1 BOTTLE (63629-9427-1) 30 capsule2022-08-230000-00-00NoNoCurrent