Home NDC 13668-443 Fluoxetine
Product NDC 13668-443
11-digit product format 136680443
Labeler code 13668
Product ID 13668-443_e509217c-e2e7-4ca7-949c-31f489e50548
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 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 · 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 · 88 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 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206937-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2016-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206937-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RS 2016-10-21 caaa826d4ba7…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…
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 10 mg/1
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
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