Fluoxetine

Product NDC
55154-1341
11-digit product format
551541341
Labeler code
55154
Product ID
55154-1341_d6e86b2b-0fe3-44bb-9e06-63e2903f60e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health
Application
ANDA076001
Marketing category
ANDA
Marketing start
2007-02-16
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
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55154-1341DDiscontinued by firm2026-08-17
excluded packagepackage55154-134155154-1341-0DDiscontinued by firm2026-08-17

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 1 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct55154-1341DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55154-134155154-1341-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A076001-001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29
A076001-002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A076001-001AB1
A076001-002AB1

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 06:07:402026-07A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076001-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A076001-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076001-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076001-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076001-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076001-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076001-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076001-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076001-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076001-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076001-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076001-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076001-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076001-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076001-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076001-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076001-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076001-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076001-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076001-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076001-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A076001-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076001-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076001-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076001-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076001-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076001-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076001-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076001-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076001-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076001-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076001-002AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076001-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076001-002AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076001-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076001-002AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076001-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076001-002AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076001-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076001-002AB11bb7c543d1eb4…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE CAPSULE [CARDINAL HEALTH]6
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE CAPSULE [CARDINAL HEALTH]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XFLUOXETINE CAPSULE [CARDINAL HEALTH]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUOXETINE CAPSULE [CARDINAL HEALTH]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE CAPSULE [CARDINAL HEALTH]6
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE CAPSULE [CARDINAL HEALTH]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUOXETINE CAPSULE [CARDINAL HEALTH]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE CAPSULE [CARDINAL HEALTH]6
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE CAPSULE [CARDINAL HEALTH]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE CAPSULE [CARDINAL HEALTH]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE CAPSULE [CARDINAL HEALTH]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-1341FLUOXETINE CAPSULE [CARDINAL HEALTH 107, LLC]16Legacy NDC20240915_a74b5d70-d673-459f-a202-2b29b85cc851.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINEREMEDYREPACK INC.24926986-7552-4f1a-8366-f035bbd071042026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINEProficient Rx LP1a2a5194-b793-4c62-a177-040dad38526b2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINEREMEDYREPACK INC.a1b40d46-5233-49d7-9833-762cb69990122026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINENorthwind Health Company, LLC4dee4a1a-360c-532e-e063-6394a90a84262026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINELegacy Pharmaceutical Packaging, LLCb07f9eab-44ac-4667-bd46-52d736daa5d62026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINEQPharma Incb4831735-6731-473a-b4f0-1f4a67aa71202025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINENCS HealthCare of KY, LLC dba Vangard Labs647e17f5-a15a-4e77-922c-24a5db2118bc2025-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINEProficient Rx LPcece294b-c414-4832-a8a2-22fb66aabda92024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINENuCare Pharmaceuticals,Inc.5631bb72-798a-6efc-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINENuCare Pharmaceuticals,Inc.78994632-74b3-951c-e053-2a91aa0ac1c82024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINEBryant Ranch Prepack7553d708-22a0-44ea-b907-7a86f2657f4c2024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINEBryant Ranch Prepack493a5946-e750-4500-afd1-8f3fdc1d420e2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINETeva Pharmaceuticals USA, Inc.06d71a33-5578-4012-b11d-764f45bc1e6a2023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-1341-05515413410010 BLISTER PACK in 1 BAG (55154-1341-0) > 1 CAPSULE in 1 BLISTER PACK10 blister pack2007-02-160000-00-00NoNoCurrent