Fluoxetine Hydrochloride

Product NDC
21695-320
11-digit product format
216950320
Labeler code
21695
Product ID
21695-320_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
10 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-320IInactivated by FDA2026-08-17
excluded packagepackage21695-32021695-320-00IInactivated by FDA2026-08-17
excluded packagepackage21695-32021695-320-90IInactivated by FDA2026-08-17

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 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-320-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-320-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-320-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-320-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-320-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-320-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-320-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-320-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-320-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-320-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-320-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-320-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-320-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-320-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-320-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-320-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-320-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-320-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-320-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-320-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-320-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-320-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-320-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-320-00557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-320-908af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-320-008af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-320-90834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-320-00834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-320-901332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-320-001332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-320-90fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-320-00fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-320-9086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-320-0086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-320-90bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-320-00bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-320-908dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-320-008dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-320-90e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-320-00e2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075755-001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-02
A075755-002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-02

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-02caaa826d4ba7…
2026-08-18 06:07:402026-07A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2001-08-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRS2001-08-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075755-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2001-08-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075755-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2001-08-02bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A075755-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075755-002AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075755-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075755-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075755-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075755-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075755-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075755-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075755-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075755-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075755-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075755-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075755-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075755-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075755-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075755-002AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce7d40ce-bfb8-ee15-a060-423ec90d7ac9Product name620250331
e5b459e3-ddce-4802-aab4-2c901d71ae85Product name520250129
6d3d5b3a-d6b8-8417-8428-6414b08f1464Product name320240130
e7177a8f-11de-ee90-ca22-068e6ef54cf5Product name420230104
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-320-002019-09-24C16284748780-1934fe258-4bff-48b1-e053-8cdaa90a720aFluoxetine
21695-320-902019-09-24C16284748780-1934fe258-4bff-48b1-e053-8cdaa90a720aFluoxetine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-320-00Fluoxetine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
21695-320-90Fluoxetine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-320-00EA - Each21695-320ac8c27c1-fb45-40e1-b590-f2a1a6691a4112012-07-24
21695-320-90EA - Each21695-320b141bf54-cd09-42d8-a30e-3570ea4c372c12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-320FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110103_10a49211-025b-4d63-b60c-fadfd9b731c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248642FLUoxetine 20 MG Oral TabletPSN10a49211-025b-4d63-b60c-fadfd9b731c01
313990FLUoxetine HCl 10 MG Oral TabletPSN10a49211-025b-4d63-b60c-fadfd9b731c01
313990fluoxetine 10 MG Oral TabletSCD10a49211-025b-4d63-b60c-fadfd9b731c01
248642fluoxetine 20 MG Oral TabletSCD10a49211-025b-4d63-b60c-fadfd9b731c01
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSY10a49211-025b-4d63-b60c-fadfd9b731c01
248642fluoxetine 20 MG (as fluoxetine hydrochloride 22.4 MG) Oral TabletSY10a49211-025b-4d63-b60c-fadfd9b731c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-320-0021695032000100 in 1 BOTTLE, PLASTICHistorical
21695-320-902169503209090 in 1 BOTTLE, PLASTICHistorical