FDA.reportPublic FDA data

ATONCY

Product NDC
30698-456
Requested package NDC
30698-456-02
11-digit product format
306980456
Labeler code
30698
Product ID
30698-456_4e746d28-ff24-2255-e063-6294a90a2c71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Validus Pharmaceuticals LLC
Application
NDA220320
Marketing category
NDA
Marketing start
2026-03-20
Substance
ATOMOXETINE HYDROCHLORIDE
Active strength
4 mg/mL
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 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220320-001ATONCYATOMOXETINE HYDROCHLORIDEEQ 4MG BASE/MLSOLUTION / ORALRLD, RS2026-03-20

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
2026-09-14 22:38:342026-08N220320-001ATONCYEQ 4MG BASE/MLSOLUTION / ORALRLD, RS2026-03-2084e616aacf4f…
2026-08-18 06:07:402026-07N220320-001ATONCYEQ 4MG BASE/MLSOLUTION / ORALRLD, RS2026-03-20caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220320-001ATONCYEQ 4MG BASE/MLSOLUTION / ORALRLD, RS2026-03-20a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOMOXETINE HYDROCHLORIDE4 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2739831Internal RxNorm lookup
2739837Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
72d3d8cf-7f3b-479e-bd9f-e204d4118517Available 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
30698-456-02ATONCY1 in 1 CARTONSOLUTION11
30698-456-02ATONCY100 mL in 1 BOTTLE, GLASSSOLUTION1001

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atomoxetine hydrochlorideATOMOXETINE HYDROCHLORIDEAdvagen Pharma Ltd.16096e9c-2dcd-4c84-a1a8-1c85d6d6898c2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 220320
application number: NDA220320
ATONCYATOMOXETINE HYDROCHLORIDEValidus Pharmaceuticals LLC72d3d8cf-7f3b-479e-bd9f-e204d41185172026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 220320
application number: NDA220320
ndc (package): 30698-456-02
ndc (product): 30698-456
ndc11 (package): 30698045602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2739831atomoxetine 4 MG/mL Oral SolutionPSN72d3d8cf-7f3b-479e-bd9f-e204d41185171
2739837atoncy 4 MG/mL Oral Solution (PSN - Release)PSN72d3d8cf-7f3b-479e-bd9f-e204d41185171
2739837atomoxetine 4 MG/ML Oral Solution [Atoncy]SBD72d3d8cf-7f3b-479e-bd9f-e204d41185171
2739831atomoxetine 4 MG/ML Oral SolutionSCD72d3d8cf-7f3b-479e-bd9f-e204d41185171
2739831atomoxetine 4 MG (as atomoxetine hydrochloride 4.57 MG) per ML Oral SolutionSY72d3d8cf-7f3b-479e-bd9f-e204d41185171
2739837Atoncy 4 MG (as atomoxetine hydrochloride 4.57 MG) per ML Oral SolutionSY72d3d8cf-7f3b-479e-bd9f-e204d41185171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
30698-456-02306980456021 BOTTLE, GLASS in 1 CARTON (30698-456-02) / 100 mL in 1 BOTTLE, GLASS2026-03-20NoNoCurrent