Home NDC 65841-611-06 atomoxetine
Product NDC 65841-611
Requested package NDC 65841-611-06
11-digit product format 658410611
Labeler code 65841
Product ID 65841-611_b4182f27-7ee6-4429-91cc-2dca5d97a119
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atomoxetine
Dosage form CAPSULE
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA079017
Marketing category ANDA
Marketing start 2017-12-06
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079017-001 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 A079017-002 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 A079017-003 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 A079017-004 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 A079017-005 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 A079017-006 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 A079017-007 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05
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.
Product history page 1 of 5 · 192 observed 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 2024-07-13 05:37 UTC 2024-07 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 301d65b070ca…2024-07-13 05:37 UTC 2024-07 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 301d65b070ca…2024-07-13 05:37 UTC 2024-07 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 301d65b070ca…2024-07-13 05:37 UTC 2024-07 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 301d65b070ca…2024-07-13 05:37 UTC 2024-07 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 301d65b070ca…2024-07-13 05:37 UTC 2024-07 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 301d65b070ca…2024-07-13 05:37 UTC 2024-07 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079017-001 ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE / ORAL AB 2010-09-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079017-002 ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2010-09-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079017-003 ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE / ORAL AB 2010-09-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079017-004 ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE / ORAL AB 2010-09-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079017-005 ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE / ORAL AB 2010-09-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079017-006 ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2010-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079017-001 ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE / ORAL AB 2010-09-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A079017-002 ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2010-09-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A079017-003 ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE / ORAL AB 2010-09-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A079017-004 ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE / ORAL AB 2010-09-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A079017-005 ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE / ORAL AB 2010-09-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A079017-006 ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2010-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079017-001 ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE / ORAL AB 2010-09-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A079017-002 ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2010-09-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A079017-003 ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE / ORAL AB 2010-09-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A079017-004 ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE / ORAL AB 2010-09-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A079017-005 ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE / ORAL AB 2010-09-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A079017-006 ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2010-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079017-001 ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE / ORAL AB 2010-09-17 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 192 observed states.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join atomoxetine ATOMOXETINE Zydus Pharmaceuticals USA Inc. 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 2025-03-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079017 application number: ANDA079017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65841-611-06 65841061106 30 CAPSULE in 1 BOTTLE (65841-611-06) 30 capsule 2017-12-06 0000-00-00 No No Current