FDA.reportPublic FDA data

Atomoxetine Hydrochloride

Product NDC
60505-2831
Requested package NDC
60505-2831-0
11-digit product format
605052831
Labeler code
60505
Product ID
60505-2831_ad1d5a70-74b7-c5db-b589-88081ba704f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA078983
Marketing category
ANDA
Marketing start
2018-05-21
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
18 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-283160505-2831-0DDiscontinued by firm2026-07-31

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
A078983-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30
A078983-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30
A078983-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30
A078983-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30
A078983-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30
A078983-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30
A078983-007ATOMOXETINE 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
A078983-001AB
A078983-002AB
A078983-003AB
A078983-004AB
A078983-005AB
A078983-006AB
A078983-007AB

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 22:54:322026-06A078983-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A078983-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A078983-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A078983-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A078983-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A078983-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A078983-007ATOMOXETINE 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 22:54:322026-06A078983-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078983-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078983-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A078983-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A078983-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A078983-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A078983-007AB1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEAvPAK9e787cc2-5d0f-f231-e053-2a95a90ae99a2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEAvPAKa9df4617-b406-70ba-e053-2995a90a28e82025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEREMEDYREPACK INC.6d7ea8f7-981c-4acc-aeaf-7516325bfc0c2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.6f14ced9-c16c-905a-e053-2a91aa0a031e2025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEApotex Corp.132852a6-5bff-15dd-255c-98309dd836302025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983
ndc (package): 60505-2831-0
ndc (product): 60505-2831
ndc11 (package): 60505283100
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEA-S Medication Solutions19b10860-aa08-4480-816c-c207819e5f9e2023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078983
application number: ANDA078983

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE18 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
132852a6-5bff-15dd-255c-98309dd83630Available 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
60505-2831-0Atomoxetine Hydrochloride10 in 1 CARTONCAPSULE1020
60505-2831-0Atomoxetine Hydrochloride10 in 1 BLISTER PACKCAPSULE1020
60505-2831-1Atomoxetine Hydrochloride100 in 1 BOTTLECAPSULE10020
60505-2831-3Atomoxetine Hydrochloride30 in 1 BOTTLECAPSULE3020
60505-2831-8Atomoxetine Hydrochloride1000 in 1 BOTTLECAPSULE100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2831-3EA - Each60505-2831e70d01c8-2a74-47d2-ab36-ea0fd5b64a9e12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2831ATOMOXETINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]20Current NDC, Legacy NDC, 5 package rows20250412_132852a6-5bff-15dd-255c-98309dd83630.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
608139atomoxetine HCl 100 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
349592atomoxetine HCl 18 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
349593atomoxetine HCl 25 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
349594atomoxetine HCl 40 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
349595atomoxetine HCl 60 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
608143atomoxetine HCl 80 MG Oral CapsulePSN132852a6-5bff-15dd-255c-98309dd8363020
349591atomoxetine 10 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
608139atomoxetine 100 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
349592atomoxetine 18 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
349593atomoxetine 25 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
349594atomoxetine 40 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
349595atomoxetine 60 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
608143atomoxetine 80 MG Oral CapsuleSCD132852a6-5bff-15dd-255c-98309dd8363020
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY132852a6-5bff-15dd-255c-98309dd8363020
349591atomoxetine HCl 10 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
608139atomoxetine HCl 100 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349592atomoxetine HCl 18 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349593atomoxetine HCl 25 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349594atomoxetine HCl 40 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349595atomoxetine HCl 60 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
608143atomoxetine HCl 80 MG Oral CapsulePSN6f14ced9-c16c-905a-e053-2a91aa0a031e12
349591atomoxetine 10 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
608139atomoxetine 100 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349592atomoxetine 18 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349593atomoxetine 25 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349594atomoxetine 40 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349595atomoxetine 60 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
608143atomoxetine 80 MG Oral CapsuleSCD6f14ced9-c16c-905a-e053-2a91aa0a031e12
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY6f14ced9-c16c-905a-e053-2a91aa0a031e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-2831-06050528310010 BLISTER PACK in 1 CARTON (60505-2831-0) > 10 CAPSULE in 1 BLISTER PACK10 blister pack2018-05-210000-00-00NoNoCurrent