FDA.reportPublic FDA data

atomoxetine

Product NDC
16714-758
11-digit product format
167140758
Labeler code
16714
Product ID
16714-758_35db9ce2-5084-4b5f-8bac-63915457cccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA079019
Marketing category
ANDA
Marketing start
2018-06-01
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
2027-12-31
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
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
ndc (product): 16714-758
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

Additional Listing Data#

Finished product
Yes
Brand name base
atomoxetine
Listing expiration
2027-12-31

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 · 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
133a4b65-762b-4712-baba-2442546f0379Available 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
16714-758-01atomoxetine30 in 1 BOTTLECAPSULE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-758-01EA - Each16714-758ade0d733-416c-4c23-9521-b53f6c0fa2ac12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-758ATOMOXETINE CAPSULE [NORTHSTAR RX LLC]5Current NDC, Legacy NDC, 1 package rows20230919_133a4b65-762b-4712-baba-2442546f0379.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
608139atomoxetine HCl 100 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
349592atomoxetine HCl 18 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
349593atomoxetine HCl 25 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
349594atomoxetine HCl 40 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
349595atomoxetine HCl 60 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
608143atomoxetine HCl 80 MG Oral CapsulePSN133a4b65-762b-4712-baba-2442546f03796
349591atomoxetine 10 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
608139atomoxetine 100 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
349592atomoxetine 18 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
349593atomoxetine 25 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
349594atomoxetine 40 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
349595atomoxetine 60 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
608143atomoxetine 80 MG Oral CapsuleSCD133a4b65-762b-4712-baba-2442546f03796
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY133a4b65-762b-4712-baba-2442546f03796

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-758-011671407580130 CAPSULE in 1 BOTTLE (16714-758-01) 30 capsule2018-06-010000-00-00NoNoCurrent