Fluoxetine

Product NDC
71335-3184
11-digit product format
713353184
Labeler code
71335
Product ID
71335-3184_30490abb-c307-49c1-8b7e-ac1b8c8b1b92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078619
Marketing category
ANDA
Marketing start
2025-07-11
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078619-001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-31
A078619-002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-31
A078619-003FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALABRS2008-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078619-001AB1
A078619-002AB1
A078619-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-31c2088c7a36db…
2026-10-15 13:18:302026-09A078619-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-31c2088c7a36db…
2026-10-15 13:18:302026-09A078619-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALABRS2008-01-31c2088c7a36db…
2026-09-14 22:38:342026-08A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-3184e616aacf4f…
2026-09-14 22:38:342026-08A078619-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-3184e616aacf4f…
2026-09-14 22:38:342026-08A078619-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALABRS2008-01-3184e616aacf4f…
2026-08-18 06:07:402026-07A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A078619-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A078619-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALABRS2008-01-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078619-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078619-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2008-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078619-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078619-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2008-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078619-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078619-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2008-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078619-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078619-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2008-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078619-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078619-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2008-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078619-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078619-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2008-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078619-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078619-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2008-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078619-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078619-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2008-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078619-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078619-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2008-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A078619-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12008-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A078619-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2008-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078619-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12008-01-3179d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A078619-001AB11c2088c7a36db…
2026-10-15 13:18:302026-09A078619-002AB11c2088c7a36db…
2026-10-15 13:18:302026-09A078619-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A078619-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A078619-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A078619-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078619-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A078619-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A078619-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078619-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078619-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078619-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078619-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078619-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078619-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078619-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078619-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078619-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078619-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078619-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078619-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078619-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078619-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078619-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078619-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078619-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078619-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078619-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078619-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078619-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078619-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078619-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078619-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078619-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078619-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078619-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078619-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078619-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078619-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078619-001AB1179d66fd596c7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE10 mg/1

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 2 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINE HYDROCHLORIDEAurobindo Pharma Limited45454555-7402-41cb-a452-e6a76e04f3872026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCda6b9b19-2ea1-9a39-e053-2995a90ad7302026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCdfae4357-b6f9-9a30-e053-2995a90a26672026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCcb66a702-7670-4a73-98fb-0e63151a1ffb2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDEQPharma Incfc754dff-cecb-fc6b-e053-6394a90ab3712025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDECardinal Health 107, LLC06394c4b-99f4-4257-bf29-53c170c5a0612025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDECouplerLLC3e111be4-28f0-c290-e063-6294a90a447f2025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDEQUALLENT PHARMACEUTICALS HEALTH LLC4abbd9d9-e9b1-463d-8f39-f3f50d80f58a2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINENorthStar Rx LLC3e1e767b-66a5-4f38-8142-84d40d447f922025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINEAurobindo Pharma Limitedd0f00a25-1aec-42fd-a301-d3710ae3e1f32025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FLUOXETINEFLUOXETINE HYDROCHLORIDEDIRECT RX9b8d8da5-8c06-0942-e053-2995a90aa2c92025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions9a151528-2fe0-4059-b7b7-fcb4e80a51e32024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions42c4c341-8282-4961-8581-8a04301625592024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions2f302db0-1c88-44cf-8258-3c1c60afb5a42024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions1226a67f-ec09-42f6-9d1b-9ddd862ea0a02024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.50345702-9869-5335-e054-00144ff88e882024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDENorthStar Rx LLC97960730-432e-4e94-bb4e-62a3157270a82024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions578ca8f8-86eb-4247-a0b3-50c3837a982e2024-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions08f3c11c-9ba0-4c53-bf31-264725e611ea2023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619
FluoxetineFLUOXETINE HYDROCHLORIDEBluePoint Laboratoriesf89a5800-6fdb-4938-a28e-3bf1aeb1c21a2023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078619
application number: ANDA078619

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3184-17133531840130 CAPSULE in 1 BOTTLE (71335-3184-1) 30 capsule2026-10-13NoNoCurrent
71335-3184-27133531840290 CAPSULE in 1 BOTTLE (71335-3184-2) 90 capsule2026-10-13NoNoCurrent
71335-3184-37133531840360 CAPSULE in 1 BOTTLE (71335-3184-3) 60 capsule2026-10-13NoNoCurrent
71335-3184-471335318404120 CAPSULE in 1 BOTTLE (71335-3184-4) 120 capsule2026-10-13NoNoCurrent
71335-3184-57133531840528 CAPSULE in 1 BOTTLE (71335-3184-5) 28 capsule2026-10-13NoNoCurrent
71335-3184-67133531840615 CAPSULE in 1 BOTTLE (71335-3184-6) 15 capsule2026-10-13NoNoCurrent
71335-3184-771335318407100 CAPSULE in 1 BOTTLE (71335-3184-7) 100 capsule2026-10-13NoNoCurrent
71335-3184-871335318408180 CAPSULE in 1 BOTTLE (71335-3184-8) 180 capsule2026-10-13NoNoCurrent