Home NDC 43598-566 Fluoxetine
Product NDC 43598-566
11-digit product format 435980566
Labeler code 43598
Product ID 43598-566_5d9a91f6-93bc-2002-8876-20139830dbb1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr.Reddy's Laboratories Inc.
Application ANDA076006
Marketing category ANDA
Marketing start 2018-05-08
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 2026-12-31
Current FDA listing Yes 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 A076006-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 A076006-002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-04-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 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 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-04-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076006-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2002-01-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076006-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-04-23 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluoxetine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOXETINE HYDROCHLORIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I9W7N6B1KJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 248642 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 43598-566-01 Fluoxetine 100 in 1 BOTTLE TABLET, FILM COATED 100 7 43598-566-10 Fluoxetine 1000 in 1 BOTTLE TABLET, FILM COATED 1000 7 43598-566-30 Fluoxetine 30 in 1 BOTTLE TABLET, FILM COATED 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-566 FLUOXETINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC.] 7 Current NDC, Legacy NDC, 3 package rows 20230906_390c61e6-14dd-4391-45b8-0fb5f4652723.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43598-566-01 43598056601 100 TABLET, FILM COATED in 1 BOTTLE (43598-566-01) 2018-05-08 0000-00-00 No No Current 43598-566-10 43598056610 1000 TABLET, FILM COATED in 1 BOTTLE (43598-566-10) 2018-05-08 0000-00-00 No No Current 43598-566-30 43598056630 30 TABLET, FILM COATED in 1 BOTTLE (43598-566-30) 2018-05-08 0000-00-00 No No Current