Home NDC 43598-632 Fluoxetine hydrochloride
Product NDC 43598-632
11-digit product format 435980632
Labeler code 43598
Product ID 43598-632_716e99cb-d17e-d5ca-61aa-3298ab7fee96
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Inc.
Application ANDA211721
Marketing category ANDA
Marketing start 2019-01-28
Substance FLUOXETINE HYDROCHLORIDE
Active strength 60 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211721-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211721-001 AB
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 2 · 41 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 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211721-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluoxetine hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOXETINE HYDROCHLORIDE 60 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 1190110 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 43598-632-01 Fluoxetine hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 5 43598-632-30 Fluoxetine hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-632 FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240523_80e52273-9741-6aef-eb24-8a93ead85ba7.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 · 2 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 43598-632-01 43598063201 100 TABLET, FILM COATED in 1 BOTTLE (43598-632-01) 2019-01-28 0000-00-00 No No Current 43598-632-30 43598063230 30 TABLET, FILM COATED in 1 BOTTLE (43598-632-30) 2019-01-28 0000-00-00 No No Current