ATOMOXETINE

Product NDC
82619-121
Requested package NDC
82619-121-02
11-digit product format
826190121
Labeler code
82619
Product ID
82619-121_587648dc-7a8b-43a9-e063-6294a90a620b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atomoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Creekwood Pharmaceuticals LLC
Application
ANDA218875
Marketing category
ANDA
Marketing start
2026-07-06
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
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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218875-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2026-06-16
A218875-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2026-06-16
A218875-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2026-06-16
A218875-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2026-06-16
A218875-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2026-06-16
A218875-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2026-06-16
A218875-007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2026-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218875-001AB
A218875-002AB
A218875-003AB
A218875-004AB
A218875-005AB
A218875-006AB
A218875-007AB

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
2026-09-14 22:38:342026-08A218875-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2026-06-1684e616aacf4f…
2026-09-14 22:38:342026-08A218875-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2026-06-1684e616aacf4f…
2026-09-14 22:38:342026-08A218875-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2026-06-1684e616aacf4f…
2026-09-14 22:38:342026-08A218875-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2026-06-1684e616aacf4f…
2026-09-14 22:38:342026-08A218875-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2026-06-1684e616aacf4f…
2026-09-14 22:38:342026-08A218875-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2026-06-1684e616aacf4f…
2026-09-14 22:38:342026-08A218875-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2026-06-1684e616aacf4f…
2026-08-18 06:07:402026-07A218875-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2026-06-16caaa826d4ba7…
2026-08-18 06:07:402026-07A218875-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2026-06-16caaa826d4ba7…
2026-08-18 06:07:402026-07A218875-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2026-06-16caaa826d4ba7…
2026-08-18 06:07:402026-07A218875-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2026-06-16caaa826d4ba7…
2026-08-18 06:07:402026-07A218875-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2026-06-16caaa826d4ba7…
2026-08-18 06:07:402026-07A218875-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2026-06-16caaa826d4ba7…
2026-08-18 06:07:402026-07A218875-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2026-06-16caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-001ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2026-06-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-002ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2026-06-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-003ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2026-06-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-004ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2026-06-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-005ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2026-06-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-006ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2026-06-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-007ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2026-06-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218875-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A218875-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A218875-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A218875-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A218875-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A218875-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A218875-007AB184e616aacf4f…
2026-08-18 06:07:402026-07A218875-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218875-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218875-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218875-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218875-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218875-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218875-007AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-005AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-006AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218875-007AB1a50c72e98297…

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
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
9b757805-eabf-4301-85be-7a3e38f6b187Available on FDA.report

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATOMOXETINEATOMOXETINECreekwood Pharmaceuticals LLC9b757805-eabf-4301-85be-7a3e38f6b1872026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218875
application number: ANDA218875
ndc (package): 82619-121-02
ndc (product): 82619-121
ndc11 (package): 82619012102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82619-121-0282619012102500 CAPSULE in 1 BOTTLE (82619-121-02) 500 capsule2026-07-06NoNoCurrent