FDA.reportPublic FDA data

Atomoxetine

Product NDC
55111-528
11-digit product format
551110528
Labeler code
55111
Product ID
55111-528_d266ad8b-af60-8e42-149b-e881323543a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA090609
Marketing category
ANDA
Marketing start
2018-02-23
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
25 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
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
ndc (product): 55111-528

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE25 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 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349591Internal RxNorm lookup
349592Internal RxNorm lookup
349593Internal RxNorm lookup
349594Internal RxNorm lookup
349595Internal RxNorm lookup
608139Internal RxNorm lookup
608143Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
973bdc9b-6421-7e00-e2b6-3cce036d363eAvailable 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
55111-528-05Atomoxetine500 in 1 BOTTLECAPSULE5008
55111-528-30Atomoxetine30 in 1 BOTTLECAPSULE308
55111-528-78Atomoxetine100 in 1 CARTONCAPSULE1008
55111-528-79Atomoxetine10 in 1 BLISTER PACKCAPSULE108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-528-30EA - Each55111-528b337d66f-b7fc-423c-a543-01c8e25937a212018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-528ATOMOXETINE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]8Current NDC, Legacy NDC, 4 package rows20220304_973bdc9b-6421-7e00-e2b6-3cce036d363e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN973bdc9b-6421-7e00-e2b6-3cce036d363e8
608139atomoxetine HCl 100 MG Oral CapsulePSN973bdc9b-6421-7e00-e2b6-3cce036d363e8
349592atomoxetine HCl 18 MG Oral CapsulePSN973bdc9b-6421-7e00-e2b6-3cce036d363e8
349593atomoxetine HCl 25 MG Oral CapsulePSN973bdc9b-6421-7e00-e2b6-3cce036d363e8
349594atomoxetine HCl 40 MG Oral CapsulePSN973bdc9b-6421-7e00-e2b6-3cce036d363e8
349595atomoxetine HCl 60 MG Oral CapsulePSN973bdc9b-6421-7e00-e2b6-3cce036d363e8
608143atomoxetine HCl 80 MG Oral CapsulePSN973bdc9b-6421-7e00-e2b6-3cce036d363e8
349591atomoxetine 10 MG Oral CapsuleSCD973bdc9b-6421-7e00-e2b6-3cce036d363e8
608139atomoxetine 100 MG Oral CapsuleSCD973bdc9b-6421-7e00-e2b6-3cce036d363e8
349592atomoxetine 18 MG Oral CapsuleSCD973bdc9b-6421-7e00-e2b6-3cce036d363e8
349593atomoxetine 25 MG Oral CapsuleSCD973bdc9b-6421-7e00-e2b6-3cce036d363e8
349594atomoxetine 40 MG Oral CapsuleSCD973bdc9b-6421-7e00-e2b6-3cce036d363e8
349595atomoxetine 60 MG Oral CapsuleSCD973bdc9b-6421-7e00-e2b6-3cce036d363e8
608143atomoxetine 80 MG Oral CapsuleSCD973bdc9b-6421-7e00-e2b6-3cce036d363e8
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY973bdc9b-6421-7e00-e2b6-3cce036d363e8
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY973bdc9b-6421-7e00-e2b6-3cce036d363e8
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY973bdc9b-6421-7e00-e2b6-3cce036d363e8
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY973bdc9b-6421-7e00-e2b6-3cce036d363e8
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY973bdc9b-6421-7e00-e2b6-3cce036d363e8
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY973bdc9b-6421-7e00-e2b6-3cce036d363e8
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY973bdc9b-6421-7e00-e2b6-3cce036d363e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-528-0555111052805500 CAPSULE in 1 BOTTLE (55111-528-05) 500 capsule2018-02-230000-00-00NoNoCurrent
55111-528-305511105283030 CAPSULE in 1 BOTTLE (55111-528-30) 30 capsule2018-02-230000-00-00NoNoCurrent
55111-528-7855111052878100 BLISTER PACK in 1 CARTON (55111-528-78) / 10 CAPSULE in 1 BLISTER PACK (55111-528-79) 100 blister pack2018-02-230000-00-00NoNoCurrent
55111-528-795511105287910 in 1 BLISTER PACKHistorical