Home NDC 0093-0807 Fluoxetine
Product NDC 0093-0807
11-digit product format 000930807
Labeler code 0093
Product ID 0093-0807_36f18cc3-526a-4448-a4fb-803303acd103
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA075872
Marketing category ANDA
Marketing start 2019-04-05
Marketing end 2023-12-31
Substance FLUOXETINE HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A075872-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 A075872-002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUOXETINE HYDROCHLORIDE ACTIVE INGREDIENT I9W7N6B1KJ FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 FLUOXETINE ACTIVE MOIETY 01K63SUP8D FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 TALC INACTIVE INGREDIENT 7SEV7J4R1U FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0093-0807-01 00093080701 100 TABLET, FILM COATED in 1 BOTTLE (0093-0807-01) 2019-04-05 0000-00-00 No No Current 0093-0807-56 00093080756 30 TABLET, FILM COATED in 1 BOTTLE (0093-0807-56) 2019-04-05 0000-00-00 No No Current