Home NDC 82619-116 ATOMOXETINE
Product NDC 82619-116
11-digit product format 826190116
Labeler code 82619
Product ID 82619-116_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 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 43 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218875-001 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2026-06-16 A218875-002 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2026-06-16 A218875-003 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2026-06-16 A218875-004 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2026-06-16 A218875-005 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2026-06-16 A218875-006 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2026-06-16 A218875-007 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2026-06-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A218875-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2026-06-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218875-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2026-06-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218875-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2026-06-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218875-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2026-06-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218875-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2026-06-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218875-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2026-06-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218875-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2026-06-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218875-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2026-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218875-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2026-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218875-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2026-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218875-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2026-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218875-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2026-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218875-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2026-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218875-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2026-06-16 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218875-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2026-06-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218875-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2026-06-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218875-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2026-06-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218875-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2026-06-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218875-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2026-06-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218875-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2026-06-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218875-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2026-06-16 a50c72e98297…
Observed Orange Book normalized TE history# 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 Ingredient Strength ATOMOXETINE HYDROCHLORIDE 18 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57WVB6I2W0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 7 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349591 Internal RxNorm lookup 349592 Internal RxNorm lookup 349593 Internal RxNorm lookup 349594 Internal RxNorm lookup 349595 Internal RxNorm lookup 608139 Internal RxNorm lookup 608143 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82619-116-01 82619011601 30 CAPSULE in 1 BOTTLE (82619-116-01) 30 capsule 2026-07-06 No No Current 82619-116-02 82619011602 500 CAPSULE in 1 BOTTLE (82619-116-02) 500 capsule 2026-07-06 No No Current