Home NDC 0781-2823-01 Fluoxetine Hydrochloride
Product NDC 0781-2823
Requested package NDC 0781-2823-01
11-digit product format 007812823
Labeler code 0781
Product ID 0781-2823_1c89f15b-eefd-4be2-9055-1374a76669cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Sandoz Inc
Application ANDA075049
Marketing category ANDA
Marketing start 2001-08-02
Marketing end 2022-10-31
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A075049-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 A075049-002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 A075049-003 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 123 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 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075049-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075049-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075049-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075049-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075049-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075049-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075049-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075049-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075049-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075049-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075049-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075049-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075049-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075049-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075049-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075049-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075049-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075049-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075049-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075049-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075049-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075049-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075049-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075049-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075049-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB1 2002-01-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075049-003 FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2002-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075049-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB1 2001-08-02 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUOXETINE HYDROCHLORIDE ACTIVE INGREDIENT I9W7N6B1KJ FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 FLUOXETINE ACTIVE MOIETY 01K63SUP8D FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 AMMONIA INACTIVE INGREDIENT 5138Q19F1X FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 GELATIN INACTIVE INGREDIENT 2G86QN327L FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 SHELLAC INACTIVE INGREDIENT 46N107B71O FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUOXETINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 17 FLUOXETINE HYDROCHLORIDE ACTIVE INGREDIENT I9W7N6B1KJ FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX] 2 FLUOXETINE ACTIVE MOIETY 01K63SUP8D FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUOXETINE HYDROCHLORIDE CAPSULE [DIRECT RX] 2 FLUOXETINE HYDROCHLORIDE ACTIVE INGREDIENT I9W7N6B1KJ FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 FLUOXETINE HYDROCHLORIDE ACTIVE INGREDIENT I9W7N6B1KJ FLUOXETINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FLUOXETINE ACTIVE MOIETY 01K63SUP8D FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 FLUOXETINE ACTIVE MOIETY 01K63SUP8D FLUOXETINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLUOXETINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLUOXETINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L FLUOXETINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUOXETINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUOXETINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUOXETINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FLUOXETINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUOXETINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUOXETINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUOXETINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
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 0781-2823-01 00781282301 100 CAPSULE in 1 BOTTLE (0781-2823-01) 100 capsule 2001-08-02 2022-08-31 No No Current