Home NDC 68788-7909 Fluoxetine
Product NDC 68788-7909
11-digit product format 687887909
Labeler code 68788
Product ID 68788-7909_df0063a3-d229-4ca6-8e82-dacc3255029a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA204597
Marketing category ANDA
Marketing start 2021-05-18
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 2027-12-31
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 2027-12-31 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 68788-7909-1 Fluoxetine 100 in 1 BOTTLE CAPSULE 100 7 68788-7909-3 Fluoxetine 30 in 1 BOTTLE CAPSULE 30 7 68788-7909-6 Fluoxetine 60 in 1 BOTTLE CAPSULE 60 7 68788-7909-9 Fluoxetine 90 in 1 BOTTLE CAPSULE 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-7909 FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 4 package rows 20250516_e83e2220-d32a-472c-bd9f-b87d0cf8858f.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 Marketing end Sample Exclude flag Status 68788-7909-1 68788790901 100 CAPSULE in 1 BOTTLE (68788-7909-1) 100 capsule 2021-05-18 0000-00-00 No No Current 68788-7909-3 68788790903 30 CAPSULE in 1 BOTTLE (68788-7909-3) 30 capsule 2021-05-18 0000-00-00 No No Current 68788-7909-6 68788790906 60 CAPSULE in 1 BOTTLE (68788-7909-6) 60 capsule 2021-05-18 0000-00-00 No No Current 68788-7909-9 68788790909 90 CAPSULE in 1 BOTTLE (68788-7909-9) 90 capsule 2021-05-18 0000-00-00 No No Current