FDA.reportPublic FDA data

atomoxetine

Product NDC
68382-218
11-digit product format
683820218
Labeler code
68382
Product ID
68382-218_8e543a65-7611-4362-94ba-0b3f929c776c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA079017
Marketing category
ANDA
Marketing start
2017-06-12
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
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
A079017-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-16
A079017-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-16
A079017-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-16
A079017-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-16
A079017-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-16
A079017-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2010-09-16
A079017-007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2023-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079017-001AB
A079017-002AB
A079017-003AB
A079017-004AB
A079017-005AB
A079017-006AB
A079017-007AB

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 22:54:322026-06A079017-001ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-002ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-003ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-004ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-005ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-006ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-007ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2023-04-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079017-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-007AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
atomoxetineATOMOXETINEZydus Pharmaceuticals USA Inc.5f89c7c9-4c25-4ba2-ad90-5aeadb48f2142025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079017
application number: ANDA079017
ndc (product): 68382-218

Additional Listing Data#

Finished product
Yes
Brand name base
atomoxetine
Listing expiration
2026-12-31

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
5f89c7c9-4c25-4ba2-ad90-5aeadb48f214Available 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
68382-218-02atomoxetine2000 in 1 BOTTLECAPSULE20006
68382-218-06atomoxetine30 in 1 BOTTLECAPSULE306
68382-218-10atomoxetine1000 in 1 BOTTLECAPSULE10006
68382-218-14atomoxetine60 in 1 BOTTLECAPSULE606
68382-218-16atomoxetine90 in 1 BOTTLECAPSULE906
68382-218-30atomoxetine10 in 1 BLISTER PACKCAPSULE106
68382-218-77atomoxetine10 in 1 CARTONCAPSULE106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-218ATOMOXETINE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 7 package rows20250326_5f89c7c9-4c25-4ba2-ad90-5aeadb48f214.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349591atomoxetine HCl 10 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608139atomoxetine HCl 100 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349592atomoxetine HCl 18 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349593atomoxetine HCl 25 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349594atomoxetine HCl 40 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349595atomoxetine HCl 60 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608143atomoxetine HCl 80 MG Oral CapsulePSN5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349591atomoxetine 10 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608139atomoxetine 100 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349592atomoxetine 18 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349593atomoxetine 25 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349594atomoxetine 40 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349595atomoxetine 60 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608143atomoxetine 80 MG Oral CapsuleSCD5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349591atomoxetine 10 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608139atomoxetine 100 MG (as atomoxetine HCl) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349592atomoxetine 18 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349593atomoxetine 25 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349594atomoxetine 40 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
349595atomoxetine 60 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146
608143atomoxetine 80 MG (as atomoxetine hydrochloride) Oral CapsuleSY5f89c7c9-4c25-4ba2-ad90-5aeadb48f2146

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-218-02683820218022000 CAPSULE in 1 BOTTLE (68382-218-02) 2000 capsule2017-06-120000-00-00NoNoCurrent
68382-218-066838202180630 CAPSULE in 1 BOTTLE (68382-218-06) 30 capsule2017-06-120000-00-00NoNoCurrent
68382-218-10683820218101000 CAPSULE in 1 BOTTLE (68382-218-10) 1000 capsule2017-06-120000-00-00NoNoCurrent
68382-218-146838202181460 CAPSULE in 1 BOTTLE (68382-218-14) 60 capsule2017-06-120000-00-00NoNoCurrent
68382-218-166838202181690 CAPSULE in 1 BOTTLE (68382-218-16) 90 capsule2017-06-120000-00-00NoNoCurrent
68382-218-306838202183010 in 1 BLISTER PACKHistorical
68382-218-776838202187710 BLISTER PACK in 1 CARTON (68382-218-77) / 10 CAPSULE in 1 BLISTER PACK (68382-218-30) 10 blister pack2017-06-120000-00-00NoNoCurrent