Fluoxetine Hydrochloride

Product NDC: 0615-5502
11-digit product format: 006155502
Labeler code: 0615
Product ID: 0615-5502_fb0613bf-4712-4563-aba8-a741a0e3f732
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA075755
Marketing category: ANDA
Marketing start: 2010-01-13
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0615-5502		D	Discontinued by firm		2026-08-03
excluded package	package	0615-5502	0615-5502-39	D	Discontinued by firm		2026-08-03

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-5502-39	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-5502-39	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-5502-39	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-5502-39	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-5502-39	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-5502-39	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-5502-39	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-5502-39	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-5502-39	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-5502-39	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-5502-39	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-5502-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-5502-39	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-5502-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-5502-39	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075755-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02
A075755-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2001-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2001-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075755-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075755-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075755-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075755-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075755-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075755-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075755-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075755-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075755-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075755-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075755-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075755-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075755-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075755-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075755-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075755-002	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-5502-39	2021-05-14	C162847	48780-1	9d75b9d0-1006-f424-e053-dadaa90a57ce	FLUOXETINE TABLETS USP Rx only
0615-5502-39	2020-01-31	C162847	48780-1	9d75b9d0-1006-f424-e053-dadaa90a57ce	FLUOXETINE TABLETS USP Rx only

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE (FLUOXETINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	15
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE HYDROCHLORIDE (FLUOXETINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUOXETINE HYDROCHLORIDE (FLUOXETINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	15
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	FLUOXETINE HYDROCHLORIDE (FLUOXETINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	15
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FLUOXETINE HYDROCHLORIDE (FLUOXETINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE HYDROCHLORIDE (FLUOXETINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	15
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FLUOXETINE HYDROCHLORIDE (FLUOXETINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUOXETINE HYDROCHLORIDE (FLUOXETINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE HYDROCHLORIDE (FLUOXETINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE HYDROCHLORIDE (FLUOXETINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	15

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE	56296-78-7	FLUOXETINE HYDROCHLORIDE
01K63SUP8D	FLUOXETINE	54910-89-3	Fluoxetine

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLUOXETINE TABLETS USP Rx only	NCS HealthCare of KY, Inc dba Vangard Labs	2013-04-09	HUMAN PRESCRIPTION DRUG LABEL	15