Fluoxetine

Product NDC
71205-178
11-digit product format
712050178
Labeler code
71205
Product ID
71205-178_42459f16-bf6e-409e-b69c-20011d31a64d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076001
Marketing category
ANDA
Marketing start
2002-01-29
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
2026-12-31
Current FDA listing
Yes

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-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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A076001-001AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A076001-002AB11782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I9W7N6B1KJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310385Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cece294b-c414-4832-a8a2-22fb66aabda9Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-178-30Fluoxetine30 in 1 BOTTLECAPSULE305
71205-178-60Fluoxetine60 in 1 BOTTLECAPSULE605
71205-178-90Fluoxetine90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-178-30EA - Each71205-17898fd9382-0a7f-420b-be9b-780bf22e7f2812019-02-13
71205-178-90EA - Each71205-178ebfba1fb-40f6-4897-8c7f-66e0801520c312020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-178FLUOXETINE CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20241024_cece294b-c414-4832-a8a2-22fb66aabda9.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
ndc (product): 71205-178
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSNcece294b-c414-4832-a8a2-22fb66aabda95
310385fluoxetine 20 MG Oral CapsuleSCDcece294b-c414-4832-a8a2-22fb66aabda95
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYcece294b-c414-4832-a8a2-22fb66aabda95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-178-307120501783030 CAPSULE in 1 BOTTLE (71205-178-30) 30 capsule2002-01-290000-00-00NoNoCurrent
71205-178-607120501786060 CAPSULE in 1 BOTTLE (71205-178-60) 60 capsule2002-01-290000-00-00NoNoCurrent
71205-178-907120501789090 CAPSULE in 1 BOTTLE (71205-178-90) 90 capsule2002-01-290000-00-00NoNoCurrent