Home NDC 68382-216 atomoxetine
Product NDC 68382-216
11-digit product format 683820216
Labeler code 68382
Product ID 68382-216_ffa27721-74b3-4ad8-b4c3-8aa29c67861c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atomoxetine
Dosage form CAPSULE
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA079017
Marketing category ANDA
Marketing start 2017-12-06
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 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 7 · 276 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 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-006 ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 2010-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079017-007 ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2023-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079017-001 ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE CAPSULE / ORAL AB 2010-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079017-002 ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 2010-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079017-003 ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2010-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079017-004 ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2010-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079017-005 ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2010-09-16 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 276 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68382-216-02 atomoxetine 2000 in 1 BOTTLE CAPSULE 2000 6 68382-216-06 atomoxetine 30 in 1 BOTTLE CAPSULE 30 6 68382-216-10 atomoxetine 1000 in 1 BOTTLE CAPSULE 1000 6 68382-216-14 atomoxetine 60 in 1 BOTTLE CAPSULE 60 6 68382-216-16 atomoxetine 90 in 1 BOTTLE CAPSULE 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-216 ATOMOXETINE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.] 6 Legacy NDC, 5 package rows 20250326_5f89c7c9-4c25-4ba2-ad90-5aeadb48f214.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 · 1 matching rows.
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 68382-216-02 68382021602 2000 CAPSULE in 1 BOTTLE (68382-216-02) 2000 capsule 2017-12-06 0000-00-00 No No Current 68382-216-06 68382021606 30 CAPSULE in 1 BOTTLE (68382-216-06) 30 capsule 2017-12-06 0000-00-00 No No Current 68382-216-10 68382021610 1000 CAPSULE in 1 BOTTLE (68382-216-10) 1000 capsule 2017-12-06 0000-00-00 No No Current 68382-216-14 68382021614 60 CAPSULE in 1 BOTTLE (68382-216-14) 60 capsule 2017-12-06 0000-00-00 No No Current 68382-216-16 68382021616 90 CAPSULE in 1 BOTTLE (68382-216-16) 90 capsule 2017-12-06 0000-00-00 No No Current