Fluoxetine

Product NDC: 54838-523
11-digit product format: 548380523
Labeler code: 54838
Product ID: 54838-523_bda5665d-4bcd-4426-9397-e438485d0d29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA077849
Marketing category: ANDA
Marketing start: 2009-08-27
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 20 mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077849-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA		2007-02-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077849-001	AA

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077849-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION / ORAL	AA	2007-02-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077849-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077849-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077849-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077849-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077849-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077849-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077849-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077849-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077849-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077849-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077849-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077849-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077849-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077849-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077849-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077849-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077849-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077849-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077849-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077849-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077849-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077849-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077849-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077849-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077849-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077849-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077849-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077849-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077849-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077849-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077849-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077849-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077849-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077849-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077849-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077849-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077849-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077849-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077849-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077849-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOXETINE HYDROCHLORIDE	20 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I9W7N6B1KJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310386	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce7d40ce-bfb8-ee15-a060-423ec90d7ac9	Product name	6	20250331
e5b459e3-ddce-4802-aab4-2c901d71ae85	Product name	5	20250129
6d3d5b3a-d6b8-8417-8428-6414b08f1464	Product name	3	20240130
e7177a8f-11de-ee90-ca22-068e6ef54cf5	Product name	4	20230104
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
82da1192-6e97-fa73-2f85-6a50c10b4704	Product name	3	20161212
877783eb-030c-6e3f-0979-804cf94d8856	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54838-523-40	Fluoxetine	120 mL in 1 BOTTLE, PLASTIC	LIQUID	120		39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54838-523-40	ML - Milliliter	54838-523	58d228df-e29c-4c63-a041-a39e514120c2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fluoxetine Hydrochloride	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]	17
Fluoxetine	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]	17
alcohol	INACTIVE INGREDIENT	3K9958V90M	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]	17
benzoic acid	INACTIVE INGREDIENT	8SKN0B0MIM	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]	17
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]	17
sucrose	INACTIVE INGREDIENT	C151H8M554	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]	17
water	INACTIVE INGREDIENT	059QF0KO0R	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]	17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54838-523	FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [LANNETT COMPANY, INC.]	39	Current NDC, Legacy NDC, 1 package rows	20230831_c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Lannett Company, Inc.	c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1	2023-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077849 application number: ANDA077849 ndc (product): 54838-523

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE	56296-78-7	FLUOXETINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310386	FLUoxetine 20 MG in 5 mL Oral Solution	PSN	c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1	39
310386	fluoxetine 4 MG/ML Oral Solution	SCD	c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1	39
310386	fluoxetine 20 MG per 5 ML Oral Solution	SY	c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1	39
310386	fluoxetine 4 MG/ML (as fluoxetine HCl) Oral Solution	SY	c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1	39

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54838-523-40	54838052340	120 mL in 1 BOTTLE, PLASTIC (54838-523-40)	120 ml	2009-08-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluoxetine	American Health Packaging	2024-01-24	HUMAN PRESCRIPTION DRUG LABEL	6
Fluoxetine	Lannett Company, Inc.	2023-08-28	HUMAN PRESCRIPTION DRUG LABEL	39