Home NDC 51655-081 Fluoxetine
Product NDC 51655-081
11-digit product format 516550081
Labeler code 51655
Product ID 51655-081_46ddcd42-e20e-656c-e063-6294a90a7e5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Northwind Health Company, LLC
Application ANDA075465
Marketing category ANDA
Marketing start 2022-10-04
Substance FLUOXETINE HYDROCHLORIDE
Active strength 40 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075465-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 A075465-002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 A075465-003 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02
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 · 123 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 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075465-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075465-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075465-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075465-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075465-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075465-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075465-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075465-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075465-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075465-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075465-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075465-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075465-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075465-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075465-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075465-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075465-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075465-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075465-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075465-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075465-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075465-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075465-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075465-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075465-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075465-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2001-08-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075465-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2002-01-29 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluoxetine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOXETINE HYDROCHLORIDE 40 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 313989 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 51655-081-26 Fluoxetine 90 in 1 BOTTLE, PLASTIC CAPSULE 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51655-081 FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [NORTHWIND PHARMACEUTICALS, LLC] 3 Current NDC, 1 package rows 20241215_f2a48124-0790-51c2-e053-2a95a90aa1af.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluoxetine FLUOXETINE HYDROCHLORIDE Northwind Health Company, LLC f2a48124-0790-51c2-e053-2a95a90aa1af 2025-12-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075465 application number: ANDA075465 ndc (product): 51655-081 Fluoxetine FLUOXETINE HYDROCHLORIDE TIME CAP LABORATORIES, INC. d7a4db7f-cdac-2b36-e053-2995a90a8d64 2024-02-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075465 application number: ANDA075465 Fluoxetine FLUOXETINE HYDROCHLORIDE MARKSANS PHARMA LIMITED 8e822937-9431-446f-88c4-330a25d12439 2023-09-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075465 application number: ANDA075465
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51655-081-26 51655008126 90 CAPSULE in 1 BOTTLE, PLASTIC (51655-081-26) 90 capsule 2022-10-04 No No Current