Home NDC 80425-0313 Fluoxetine
Product NDC 80425-0313
11-digit product format 804250313
Labeler code 80425
Product ID 80425-0313_2a9bf7d3-46d9-0dfa-e063-6394a90a76a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine
Dosage form CAPSULE
Route ORAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA204597
Marketing category ANDA
Marketing start 2023-04-11
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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204597-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 A204597-002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 A204597-003 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 132 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 2026-10-15 13:18:30 2026-09 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204597-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2015-03-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204597-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2015-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204597-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2015-03-16 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 310385 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 80425-0313-1 Fluoxetine 30 in 1 BOTTLE CAPSULE 30 2 80425-0313-2 Fluoxetine 60 in 1 BOTTLE CAPSULE 60 2 80425-0313-3 Fluoxetine 90 in 1 BOTTLE CAPSULE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0313 FLUOXETINE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 2 Current NDC, 3 package rows 20250102_f917063a-226e-0978-e053-6294a90aeb4b.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 3 of 3 · 42 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 80425-0313-1 80425031301 30 CAPSULE in 1 BOTTLE (80425-0313-1) 30 capsule 2023-04-11 No No Current 80425-0313-2 80425031302 60 CAPSULE in 1 BOTTLE (80425-0313-2) 60 capsule 2023-04-11 No No Current 80425-0313-3 80425031303 90 CAPSULE in 1 BOTTLE (80425-0313-3) 90 capsule 2023-04-11 No No Current