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 44 .
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 2 of 3 · 88 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 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…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2002-01-29 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2019-01-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075872-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-29 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075872-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-04 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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