FDA.reportPublic FDA data

Atomoxetine

Product NDC
65862-244
11-digit product format
658620244
Labeler code
65862
Product ID
65862-244_48d5f73a-bdcc-466a-aa17-53c0a38c3b3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA079016
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
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-244UNFINISHEDActive or certified unfinished drug listing2026-08-03
unfinished packagepackage65862-24465862-244-15UNFINISHEDActive or certified unfinished drug listing2026-08-03

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
A079016-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30
A079016-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30
A079016-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30
A079016-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30
A079016-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30
A079016-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30
A079016-007ATOMOXETINE 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
A079016-001AB
A079016-002AB
A079016-003AB
A079016-004AB
A079016-005AB
A079016-006AB
A079016-007AB

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 22:54:322026-06A079016-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079016-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079016-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079016-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079016-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079016-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079016-007ATOMOXETINE 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 22:54:322026-06A079016-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079016-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A079016-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A079016-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A079016-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A079016-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A079016-007AB1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtomoxetineATOMOXETINEAmerican Health Packaging10d36b32-0202-4c03-8a1a-cd5d53f231e72026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
AtomoxetineATOMOXETINEBryant Ranch Prepack35b42f0c-a183-478b-bced-652dc12b33ec2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
AtomoxetineATOMOXETINEAurobindo Pharma Limited6f6bea0c-297b-43ff-8960-ecc11243e06e2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
ndc (product): 65862-244
AtomoxetineATOMOXETINERising Pharma Holdings, Inc.1cceab35-dc4a-40bc-a245-10b64820e2172025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
AtomoxetineATOMOXETINEA-S Medication Solutions50a20478-5f33-4ecd-b5d3-dbba855e5f6b2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
AtomoxetineATOMOXETINEBryant Ranch Prepackd4fe9217-1853-4f8b-9a93-77e511554ca12025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
AtomoxetineATOMOXETINEA-S Medication Solutions24bb7238-7e12-48d1-a572-2c753e69f6042023-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016
AtomoxetineATOMOXETINEA-S Medication Solutionsffdcc267-d6ae-41ee-97d9-2c7596545ce82023-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079016
application number: ANDA079016

Additional Listing Data#

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

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 · 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
6f6bea0c-297b-43ff-8960-ecc11243e06eAvailable 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
65862-244-05Atomoxetine500 in 1 BOTTLECAPSULE50016
65862-244-30Atomoxetine30 in 1 BOTTLECAPSULE3016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-244ATOMOXETINE CAPSULE [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 2 package rows20240215_6f6bea0c-297b-43ff-8960-ecc11243e06e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
608139atomoxetine HCl 100 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
349592atomoxetine HCl 18 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
349593atomoxetine HCl 25 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
349594atomoxetine HCl 40 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
349595atomoxetine HCl 60 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
608143atomoxetine HCl 80 MG Oral CapsulePSN6f6bea0c-297b-43ff-8960-ecc11243e06e16
349591atomoxetine 10 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
608139atomoxetine 100 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
349592atomoxetine 18 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
349593atomoxetine 25 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
349594atomoxetine 40 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
349595atomoxetine 60 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
608143atomoxetine 80 MG Oral CapsuleSCD6f6bea0c-297b-43ff-8960-ecc11243e06e16
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f6bea0c-297b-43ff-8960-ecc11243e06e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-244-0565862024405500 CAPSULE in 1 BOTTLE (65862-244-05) 500 capsule2017-05-300000-00-00NoNoCurrent
65862-244-15658620244151500 CAPSULE in 1 BAG (65862-244-15)1500 capsule30-MAY-17Current
65862-244-306586202443030 CAPSULE in 1 BOTTLE (65862-244-30) 30 capsule2017-05-300000-00-00NoNoCurrent