Home NDC 84386-106-30 Fluoxetine
Product NDC 84386-106
Requested package NDC 84386-106-30
11-digit product format 843860106
Labeler code 84386
Product ID 84386-106_bed68a4a-234d-4871-b61a-90bc7e10f61e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA213265
Marketing category ANDA
Marketing start 2026-01-15
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A213265-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB RS 2020-06-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213265-001 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.
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 2026-09-14 22:38:34 2026-08 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB RS 2020-06-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB RS 2020-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB RS 2020-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB RS 2020-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB RS 2020-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-06-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213265-001 FLUOXETINE HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB RS 2020-06-10 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 84386-106-30 Fluoxetine 30 in 1 BOTTLE TABLET, FILM COATED 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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84386-106-30 84386010630 30 TABLET, FILM COATED in 1 BOTTLE (84386-106-30) 2026-01-15 No No Current