Home NDC 71656-089 FLUOXETINE
Product NDC 71656-089
11-digit product format 716560089
Labeler code 71656
Product ID 71656-089_38420669-08b4-a3e4-e063-6294a90a4573
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUOXETINE
Dosage form SOLUTION
Route ORAL
Labeler Saptalis Pharmaceuticals, LLC.
Application ANDA075525
Marketing category ANDA
Marketing start 2025-06-20
Substance FLUOXETINE HYDROCHLORIDE
Active strength 20 mg/5mL
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 42 .
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 A075525-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2002-06-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075525-001 AA
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 · 42 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 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2002-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2002-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2002-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2002-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075525-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL 2002-06-27 e64feba35796…
Observed Orange Book normalized TE history# 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/5mL
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 310386 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 71656-089-04 FLUOXETINE 120 mL in 1 BOTTLE SOLUTION 120 1
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71656-089-04 71656008904 120 mL in 1 BOTTLE (71656-089-04) 120 ml 2025-06-20 No No Current