Home NDC 50228-638 Fluoxetine
Product NDC 50228-638
11-digit product format 502280638
Labeler code 50228
Product ID 50228-638_3e89095f-77b2-4fde-e063-6294a90a1ff3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUOXETINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler ScieGen Pharmaceuticals, Inc.
Application ANDA211282
Marketing category ANDA
Marketing start 2025-09-11
Substance FLUOXETINE HYDROCHLORIDE
Active strength 60 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211282-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211282-001 AB
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 2 · 41 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 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211282-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2019-01-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 60 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 1190110 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 50228-638-10 Fluoxetine 1000 in 1 BOTTLE TABLET 1000 1 50228-638-30 Fluoxetine 30 in 1 BOTTLE TABLET 30 1
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 · 2 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 50228-638-10 50228063810 1000 TABLET in 1 BOTTLE (50228-638-10) 1000 tablet 2025-09-11 No No Current 50228-638-30 50228063830 30 TABLET in 1 BOTTLE (50228-638-30) 30 tablet 2025-09-11 No No Current