Home NDC 21695-321 Fluoxetine Hydrochloride
Product NDC 21695-321
11-digit product format 216950321
Labeler code 21695
Product ID 21695-321_10a49211-025b-4d63-b60c-fadfd9b731c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluoxetine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rebel Distributors Corp
Application ANDA075755
Marketing category ANDA
Marketing start 2010-01-13
Marketing end 0000-00-00
Substance FLUOXETINE HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 110 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A075755-001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 A075755-002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02
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 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2001-08-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2001-08-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075755-001 FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2001-08-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075755-002 FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2001-08-02 782e0a99824c…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21695-321-00 Fluoxetine Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 1 21695-321-30 Fluoxetine Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1 21695-321-60 Fluoxetine Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 1 21695-321-90 Fluoxetine Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUOXETINE HYDROCHLORIDE ACTIVE INGREDIENT I9W7N6B1KJ FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 FLUOXETINE ACTIVE MOIETY 01K63SUP8D FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-321 FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 4 package rows 20110103_10a49211-025b-4d63-b60c-fadfd9b731c0.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 21695-321-00 21695032100 100 in 1 BOTTLE, PLASTIC Historical 21695-321-30 21695032130 30 in 1 BOTTLE, PLASTIC Historical 21695-321-60 21695032160 60 in 1 BOTTLE, PLASTIC Historical 21695-321-90 21695032190 90 in 1 BOTTLE, PLASTIC Historical