Home NDC 63629-9427 Atomoxetine
Product NDC 63629-9427
11-digit product format 636299427
Labeler code 63629
Product ID 63629-9427_42ef39aa-5c53-44e0-b9c9-4426104749f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atomoxetine
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA090609
Marketing category ANDA
Marketing start 2018-02-23
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 42 .
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 A090609-001 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2018-02-23 A090609-002 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2018-02-23 A090609-003 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2018-02-23 A090609-004 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2018-02-23 A090609-005 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2018-02-23 A090609-006 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2018-02-23 A090609-007 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2018-02-23
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 8 · 294 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 2026-08-18 06:07:40 2026-07 A090609-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2018-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090609-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2018-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090609-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2018-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090609-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2018-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090609-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2018-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090609-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2018-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090609-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2018-02-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090609-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2018-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090609-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2018-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090609-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2018-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090609-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2018-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090609-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2018-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090609-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2018-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090609-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2018-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090609-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2018-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090609-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2018-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090609-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2018-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090609-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2018-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090609-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2018-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090609-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2018-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090609-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2018-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090609-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2018-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090609-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2018-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090609-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2018-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090609-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2018-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090609-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2018-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090609-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2018-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090609-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2018-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090609-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2018-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090609-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2018-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090609-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2018-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090609-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2018-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090609-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2018-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090609-006 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2018-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090609-007 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2018-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090609-001 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2018-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090609-002 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2018-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090609-003 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2018-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090609-004 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2018-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090609-005 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2018-02-23 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 294 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Atomoxetine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATOMOXETINE HYDROCHLORIDE 40 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349594 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-9427-1 Atomoxetine 30 in 1 BOTTLE CAPSULE 30 101
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-9427 ATOMOXETINE CAPSULE [BRYANT RANCH PREPACK] 101 Current NDC, Legacy NDC, 1 package rows 20231021_b7f78a37-d525-42b7-813a-fa3e18ae7b74.zip
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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Atomoxetine ATOMOXETINE REMEDYREPACK INC. d7002d75-edad-4141-91bf-7eebf50ad1aa 2025-10-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090609 application number: ANDA090609 Atomoxetine ATOMOXETINE Major Pharmaceuticals f98c3424-1c43-43e4-8bca-2e3430f50c63 2025-03-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090609 application number: ANDA090609 Atomoxetine ATOMOXETINE Bryant Ranch Prepack b7f78a37-d525-42b7-813a-fa3e18ae7b74 2023-10-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090609 application number: ANDA090609 ndc (product): 63629-9427 Atomoxetine ATOMOXETINE Bryant Ranch Prepack 92de0ca1-6a02-4925-aefc-b32573d349a7 2023-10-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090609 application number: ANDA090609 Atomoxetine ATOMOXETINE Dr. Reddy's Laboratories Limited 973bdc9b-6421-7e00-e2b6-3cce036d363e 2022-01-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090609 application number: ANDA090609
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-9427-1 63629942701 30 CAPSULE in 1 BOTTLE (63629-9427-1) 30 capsule 2022-08-23 0000-00-00 No No Current