Fluoxetine hydrochloride

Product NDC: 55111-284
11-digit product format: 551110284
Labeler code: 55111
Product ID: 55111-284_42f4ab4e-3271-f7cc-8e57-e621d0d3e1d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluoxetine Hydrochloride
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Labeler: Dr.Reddy's Laboratories Limited
Application: ANDA078572
Marketing category: ANDA
Marketing start: 2010-03-24
Substance: FLUOXETINE HYDROCHLORIDE
Active strength: 90 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 43.

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
A078572-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RS	2010-03-22

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078572-001	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RS	2010-03-22	`f41ea6bd6efb…`

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 hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOXETINE HYDROCHLORIDE	90 mg/1

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
313995	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
887fc670-db67-4cfe-967b-46b38375dae5	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
82da1192-6e97-fa73-2f85-6a50c10b4704	Product name	3	20161212
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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
55111-284-48	Fluoxetine hydrochloride	1 in 1 CARTON	CAPSULE, DELAYED RELEASE PELLETS	1		20
55111-284-48	Fluoxetine hydrochloride	4 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE PELLETS	4		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-284-48	EA - Each	55111-284	28992afd-8571-4b05-a79f-4d2c0ef8f279	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fluoxetine hydrochloride	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
Fluoxetine	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
gelatin	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
glycine	INACTIVE INGREDIENT	TE7660XO1C	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)	INACTIVE INGREDIENT	87Y6436BKR	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
methylene chloride	INACTIVE INGREDIENT	588X2YUY0A	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
povidone	INACTIVE INGREDIENT	FZ989GH94E	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
raw sugar	INACTIVE INGREDIENT	8M707QY5GH	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
talc	INACTIVE INGREDIENT	7SEV7J4R1U	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-284	FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED]	20	Current NDC, Legacy NDC, 2 package rows	20250522_887fc670-db67-4cfe-967b-46b38375dae5.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 hydrochloride	FLUOXETINE HYDROCHLORIDE	Dr.Reddy's Laboratories Limited	887fc670-db67-4cfe-967b-46b38375dae5	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078572 application number: ANDA078572 ndc (product): 55111-284

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
313995	FLUoxetine 90 MG Delayed Release Oral Capsule	PSN	887fc670-db67-4cfe-967b-46b38375dae5	20
313995	fluoxetine 90 MG Delayed Release Oral Capsule	SCD	887fc670-db67-4cfe-967b-46b38375dae5	20
313995	fluoxetine 90 MG (fluoxetine hydrochloride 101 MG) Delayed Release Oral Capsule	SY	887fc670-db67-4cfe-967b-46b38375dae5	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-284-48	55111028448	1 BLISTER PACK in 1 CARTON (55111-284-48) / 4 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK	1 blister pack	2010-03-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluoxetine hydrochloride	Dr.Reddy's Laboratories Limited \| Dr.Reddy's Laboratories Limited (FTO III)	2026-06-22	HUMAN PRESCRIPTION DRUG LABEL	21