Home NDC 43063-197 FLUOXETINE
Product NDC 43063-197
11-digit product format 430630197
Labeler code 43063
Product ID 43063-197_a8d98511-f38c-76c3-e053-2a95a90a9bd3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluoxetine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA076922
Marketing category ANDA
Marketing start 2008-10-14
Marketing end 2021-10-31
Substance FLUOXETINE HYDROCHLORIDE
Active strength 40 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076922-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2004-12-16 A076922-002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2004-12-16 A076922-003 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL 2004-12-16
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 4 · 129 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 2026-09-14 22:38:34 2026-08 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2004-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076922-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2004-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076922-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL 2004-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2004-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076922-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2004-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076922-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL 2004-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2004-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076922-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2004-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076922-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL 2004-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2004-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076922-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2004-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076922-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2004-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2004-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076922-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2004-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076922-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2004-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2004-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076922-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2004-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076922-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2004-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2004-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076922-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2004-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076922-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2004-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2004-12-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076922-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2004-12-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076922-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2004-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2004-12-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076922-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2004-12-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076922-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2004-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2004-12-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076922-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2004-12-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076922-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL 2004-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2004-12-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076922-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2004-12-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076922-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2004-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2004-12-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076922-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2004-12-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076922-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2004-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2004-12-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076922-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2004-12-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076922-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL 2004-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076922-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2004-12-16 301d65b070ca…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUOXETINE HYDROCHLORIDE ACTIVE INGREDIENT I9W7N6B1KJ FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 6 FLUOXETINE ACTIVE MOIETY 01K63SUP8D FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 6 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 6 GELATIN INACTIVE INGREDIENT 2G86QN327L FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 6 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43063-197-30 43063019730 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-197-30) 30 capsule 2011-06-21 2021-10-31 No No Current 43063-197-90 43063019790 90 CAPSULE in 1 BOTTLE, PLASTIC (43063-197-90) 90 capsule 2015-04-14 2021-10-31 No No Current