FDA.reportPublic FDA data

Atomoxetine

Product NDC
64380-478
11-digit product format
643800478
Labeler code
64380
Product ID
64380-478_27a196c2-92d8-4c4f-97e5-210ae78dedbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA079021
Marketing category
ANDA
Marketing start
2025-07-01
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

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
A079021-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-02-18
A079021-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2021-02-18
A079021-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-02-18
A079021-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2021-02-18
A079021-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2021-02-18
A079021-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2021-02-18
A079021-007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A079021-001AB
A079021-002AB
A079021-003AB
A079021-004AB
A079021-005AB
A079021-006AB
A079021-007AB

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 22:54:322026-06A079021-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-02-18a50c72e98297…
2026-08-01 22:54:322026-06A079021-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2021-02-18a50c72e98297…
2026-08-01 22:54:322026-06A079021-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-02-18a50c72e98297…
2026-08-01 22:54:322026-06A079021-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2021-02-18a50c72e98297…
2026-08-01 22:54:322026-06A079021-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2021-02-18a50c72e98297…
2026-08-01 22:54:322026-06A079021-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2021-02-18a50c72e98297…
2026-08-01 22:54:322026-06A079021-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-02-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079021-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079021-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A079021-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A079021-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A079021-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A079021-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A079021-007AB1a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtomoxetineATOMOXETINEBryant Ranch Prepack47cd1d85-fbc1-4309-9365-58bacf108f5b2026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079021
application number: ANDA079021
AtomoxetineATOMOXETINEBryant Ranch Prepackb00eb367-d7cc-42fa-91af-a1a5f90dbb412025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079021
application number: ANDA079021
AtomoxetineATOMOXETINEBryant Ranch Prepackbb2c12e4-563c-417e-bee1-6d8c51e75af42025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079021
application number: ANDA079021
AtomoxetineATOMOXETINEBryant Ranch Prepackc5e9e305-8d99-4234-b531-6ade177768b72025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079021
application number: ANDA079021
AtomoxetineATOMOXETINEBryant Ranch Prepack1d26aff3-72a7-4a5b-a6fe-44dc8a08b1962025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079021
application number: ANDA079021
AtomoxetineATOMOXETINEBryant Ranch Prepack9c1f858c-8721-49e3-be8b-bf180e89ff422025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079021
application number: ANDA079021
AtomoxetineATOMOXETINEBryant Ranch Prepackbbb2a8f6-0816-47b1-830a-ef23e97d498f2025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079021
application number: ANDA079021
AtomoxetineATOMOXETINEBryant Ranch Prepackc6542d69-d0a2-4663-9172-943f9f6f53252025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079021
application number: ANDA079021
AtomoxetineATOMOXETINEStrides Pharma Science Limited2614df7e-0b16-4b03-883e-141d4ec34b352025-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079021
application number: ANDA079021
ndc (product): 64380-478

Additional Listing Data#

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

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
2614df7e-0b16-4b03-883e-141d4ec34b35Available 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
64380-478-01Atomoxetine30 in 1 BOTTLE, PLASTICCAPSULE301
64380-478-02Atomoxetine500 in 1 BOTTLE, PLASTICCAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-478-01EA - Each64380-478f2829af6-a437-437f-ba75-82a7fb76747812025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
608139atomoxetine HCl 100 MG Oral CapsulePSNc6542d69-d0a2-4663-9172-943f9f6f5325100
608139atomoxetine 100 MG Oral CapsuleSCDc6542d69-d0a2-4663-9172-943f9f6f5325100
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSYc6542d69-d0a2-4663-9172-943f9f6f5325100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64380-478-016438004780130 CAPSULE in 1 BOTTLE, PLASTIC (64380-478-01) 30 capsule2025-07-01NoNoCurrent
64380-478-0264380047802500 CAPSULE in 1 BOTTLE, PLASTIC (64380-478-02) 500 capsule2025-07-01NoNoCurrent