Home NDC 0832-6032 Fluoxetine hydrochloride
Product NDC 0832-6032
11-digit product format 008326032
Labeler code 0832
Product ID 0832-6032_178bf3b7-fdee-454e-9446-822a1077d985
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine hydrochloride
Dosage form FOR SOLUTION
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA216953
Marketing category ANDA
Marketing start 2022-11-15
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 1 .
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 A216953-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216953-001 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.
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 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216953-001 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION / ORAL AA 2022-11-15 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fluoxetine hydrochloride
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 0832-6032-12 Fluoxetine hydrochloride 120 mL in 1 BOTTLE FOR SOLUTION 120 5 0832-6032-12 Fluoxetine hydrochloride 1 in 1 CARTON FOR SOLUTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0832-6032 FLUOXETINE HYDROCHLORIDE FOR SOLUTION [UPSHER-SMITH LABORATORIES, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20231011_be2e4325-feb9-4957-99c0-0a741a2d71a0.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 · 1 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 0832-6032-12 00832603212 1 BOTTLE in 1 CARTON (0832-6032-12) / 120 mL in 1 BOTTLE 1 bottle 2022-11-30 0000-00-00 No No Current