FDA.reportPublic FDA data

Atomoxetine

Product NDC
31722-715
11-digit product format
317220715
Labeler code
31722
Product ID
31722-715_52a3d33b-4b01-9de5-e063-6294a90ae28d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA202682
Marketing category
ANDA
Marketing start
2021-03-11
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
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
A202682-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-03-11
A202682-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2021-03-11
A202682-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-03-11
A202682-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2021-03-11
A202682-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALABRS2021-03-11
A202682-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2021-03-11
A202682-007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-03-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202682-001AB
A202682-002AB
A202682-003AB
A202682-004AB
A202682-005AB
A202682-006AB
A202682-007AB

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 22:54:322026-06A202682-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2021-03-11a50c72e98297…
2026-08-01 22:54:322026-06A202682-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2021-03-11a50c72e98297…
2026-08-01 22:54:322026-06A202682-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2021-03-11a50c72e98297…
2026-08-01 22:54:322026-06A202682-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2021-03-11a50c72e98297…
2026-08-01 22:54:322026-06A202682-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALABRS2021-03-11a50c72e98297…
2026-08-01 22:54:322026-06A202682-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2021-03-11a50c72e98297…
2026-08-01 22:54:322026-06A202682-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2021-03-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202682-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202682-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202682-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A202682-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A202682-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A202682-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A202682-007AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtomoxetineATOMOXETINECamber Pharmaceuticals, Inc.f266ab7b-5a68-42b5-b204-e3249bea0aed2026-05-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202682
application number: ANDA202682
ndc (product): 31722-715
AtomoxetineATOMOXETINEA-S Medication Solutions652cb30f-4368-4009-93a3-3a0d2a365f422026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202682
application number: ANDA202682
AtomoxetineATOMOXETINENorthStar RxLLC14f2804d-2914-4dd9-86c0-d084fcfd7e502026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202682
application number: ANDA202682
AtomoxetineATOMOXETINEA-S Medication Solutions14fb8a4c-c2bf-4d44-bea9-cd159c2ca5fa2023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202682
application number: ANDA202682
AtomoxetineATOMOXETINEA-S Medication Solutions0782204e-56a3-4439-9fb8-194da94870492023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202682
application number: ANDA202682

Additional Listing Data#

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

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
f266ab7b-5a68-42b5-b204-e3249bea0aedAvailable 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
31722-715-30Atomoxetine30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-715-30EA - Each31722-715ccd1c197-70a9-4040-8fbe-615f795323ac12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-715ATOMOXETINE (ATOMOXETINE) CAPSULE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 1 package rows20210321_f266ab7b-5a68-42b5-b204-e3249bea0aed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
608139atomoxetine HCl 100 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
349592atomoxetine HCl 18 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
349593atomoxetine HCl 25 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
349594atomoxetine HCl 40 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
349595atomoxetine HCl 60 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
608143atomoxetine HCl 80 MG Oral CapsulePSNf266ab7b-5a68-42b5-b204-e3249bea0aed2
349591atomoxetine 10 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
608139atomoxetine 100 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
349592atomoxetine 18 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
349593atomoxetine 25 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
349594atomoxetine 40 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
349595atomoxetine 60 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
608143atomoxetine 80 MG Oral CapsuleSCDf266ab7b-5a68-42b5-b204-e3249bea0aed2
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSYf266ab7b-5a68-42b5-b204-e3249bea0aed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-715-303172207153030 CAPSULE in 1 BOTTLE (31722-715-30) 30 capsule2021-03-110000-00-00NoNoCurrent