FDA.reportPublic FDA data

atomoxetine

Product NDC
70518-2474
Requested package NDC
70518-2474-0
11-digit product format
705182474
Labeler code
70518
Product ID
70518-2474_c9605376-7e12-58ff-e053-2a95a90a3c51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA079019
Marketing category
ANDA
Marketing start
2019-12-09
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage70518-247470518-2474-0DDiscontinued 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
A079019-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30
A079019-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30
A079019-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30
A079019-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30
A079019-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30
A079019-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30
A079019-007ATOMOXETINE 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
A079019-001AB
A079019-002AB
A079019-003AB
A079019-004AB
A079019-005AB
A079019-006AB
A079019-007AB

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 22:54:322026-06A079019-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079019-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079019-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079019-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079019-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079019-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-05-30a50c72e98297…
2026-08-01 22:54:322026-06A079019-007ATOMOXETINE 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 22:54:322026-06A079019-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079019-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A079019-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A079019-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A079019-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A079019-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A079019-007AB1a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
atomoxetineATOMOXETINEBryant Ranch Prepack97a4aa63-0877-40e5-94c4-ea487db5691d2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019
atomoxetineATOMOXETINEA-S Medication Solutions90f45a1e-f79f-468f-b21b-5dc82f5717aa2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019
atomoxetineATOMOXETINENorthstar Rx LLC133a4b65-762b-4712-baba-2442546f03792026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019
atomoxetineATOMOXETINEGlenmark Pharmaceuticals Inc., USA0ab8d905-e890-4e91-a730-3e5d12f5c23f2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019
atomoxetineATOMOXETINEA-S Medication Solutionsf75bc8e2-8e8e-4883-be9c-b716842c52772024-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019
atomoxetineATOMOXETINEA-S Medication Solutions793928fb-fbcb-4fc6-90d4-f8a15e6b1f932024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019
atomoxetineATOMOXETINEA-S Medication Solutions47f6faeb-52b5-4b04-bf34-de5db8eb46dc2024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079019
application number: ANDA079019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2474-07051824740030 POUCH in 1 BOX (70518-2474-0) > 1 CAPSULE in 1 POUCH (70518-2474-1) 30 pouch2019-12-090000-00-00NoNoCurrent