Home NDC 0615-1384 Fluoxetine
Product NDC 0615-1384
11-digit product format 006151384
Labeler code 0615
Product ID 0615-1384_58fe7d20-4803-4761-9098-d859806b0564
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA076287
Marketing category ANDA
Marketing start 2008-05-20
Marketing end 0000-00-00
Substance FLUOXETINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-1384-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-1384-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-1384-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-1384-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-1384-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-1384-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-1384-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-1384-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-1384-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-1384-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-1384-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-1384-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0615-1384-39 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0615-1384-39 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0615-1384-39 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0615-1384-39 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-1384-39 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-1384-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-1384-39 I Inactivated by FDA 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076287-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 A076287-002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20
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 3 · 84 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 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076287-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2008-05-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076287-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2008-05-20 bb7c543d1eb4…
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