Home NDC 13668-443 Fluoxetine
Product NDC 13668-443
11-digit product format 136680443
Labeler code 13668
Product ID 13668-443_f8d8c930-c8f9-4186-92fa-6f7a5dabe083
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA206937
Marketing category ANDA
Marketing start 2016-10-21
Substance FLUOXETINE HYDROCHLORIDE
Active strength 10 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206937-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 A206937-002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21
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 3 · 82 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 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB1 2016-10-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB1 2016-10-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 782e0a99824c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fluoxetine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOXETINE HYDROCHLORIDE 10 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2532159 Internal RxNorm lookup 2532163 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-443 FLUOXETINE TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 Current NDC, Legacy NDC, 5 package rows 20241213_dcebc7cf-6f95-4f7a-a22b-c7d2e0f04d74.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 13668-443-01 13668044301 100 TABLET in 1 BOTTLE (13668-443-01) 100 tablet 2016-10-21 0000-00-00 No No Current 13668-443-10 13668044310 1000 TABLET in 1 BOTTLE (13668-443-10) 1000 tablet 2016-10-21 0000-00-00 No No Current 13668-443-30 13668044330 30 TABLET in 1 BOTTLE (13668-443-30) 30 tablet 2016-10-21 0000-00-00 No No Current 13668-443-74 13668044374 100 TABLET in 1 CARTON (13668-443-74) 100 tablet 2016-10-21 0000-00-00 No No Current 13668-443-91 13668044391 28 TABLET in 1 CARTON (13668-443-91) 28 tablet 2016-10-21 0000-00-00 No No Current