Home NDC 43063-839 Fluoxetine
Product NDC 43063-839
11-digit product format 430630839
Labeler code 43063
Product ID 43063-839_32851291-33ce-2831-e063-6294a90a0d3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA090223
Marketing category ANDA
Marketing start 2016-01-29
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 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090223-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 A090223-002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 A090223-003 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19
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 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090223-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090223-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090223-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090223-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090223-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090223-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090223-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090223-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090223-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090223-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090223-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090223-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090223-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090223-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090223-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090223-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090223-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090223-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090223-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090223-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090223-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090223-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090223-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090223-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090223-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2009-03-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090223-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2009-03-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090223-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2009-03-19 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 2026-12-31 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 43063-839-30 Fluoxetine 30 in 1 BOTTLE, PLASTIC CAPSULE 30 16 43063-839-90 Fluoxetine 90 in 1 BOTTLE, PLASTIC CAPSULE 90 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-839 FLUOXETINE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 16 Current NDC, Legacy NDC, 2 package rows 20250413_620ecf00-5473-4420-afd1-94b5b38e7301.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 Units Marketing start Marketing end Sample Exclude flag Status 43063-839-30 43063083930 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-839-30) 30 capsule 2016-01-29 0000-00-00 No No Current 43063-839-90 43063083990 90 CAPSULE in 1 BOTTLE, PLASTIC (43063-839-90) 90 capsule 2018-03-06 0000-00-00 No No Current