Fluoxetine

Product NDC: 63187-233
11-digit product format: 631870233
Labeler code: 63187
Product ID: 63187-233_d8af1a25-3072-4c46-a287-61f19bb7b5c9
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: 10 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076001-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1		2002-01-29
A076001-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1		2002-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076001-001	AB1
A076001-002	AB1

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076001-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076001-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A076001-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076001-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076001-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076001-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076001-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076001-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076001-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076001-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076001-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076001-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076001-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076001-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076001-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076001-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076001-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076001-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076001-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076001-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076001-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076001-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076001-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076001-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076001-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076001-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076001-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076001-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076001-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076001-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076001-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076001-002	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076001-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076001-002	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076001-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076001-002	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076001-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076001-002	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076001-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076001-002	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076001-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076001-002	AB1	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOXETINE HYDROCHLORIDE	10 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
310384	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
1a2a5194-b793-4c62-a177-040dad38526b	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
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
63187-233-30	Fluoxetine	30 in 1 BOTTLE	CAPSULE	30		6
63187-233-90	Fluoxetine	90 in 1 BOTTLE	CAPSULE	90		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUOXETINE CAPSULE [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-233	FLUOXETINE CAPSULE [PROFICIENT RX LP]	5	Current NDC, Legacy NDC, 2 package rows	20241024_1a2a5194-b793-4c62-a177-040dad38526b.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE	REMEDYREPACK INC.	24926986-7552-4f1a-8366-f035bbd07104	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Proficient Rx LP	1a2a5194-b793-4c62-a177-040dad38526b	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001 ndc (product): 63187-233
Fluoxetine	FLUOXETINE	REMEDYREPACK INC.	a1b40d46-5233-49d7-9833-762cb6999012	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Northwind Health Company, LLC	4dee4a1a-360c-532e-e063-6394a90a8426	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Legacy Pharmaceutical Packaging, LLC	b07f9eab-44ac-4667-bd46-52d736daa5d6	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	QPharma Inc	b4831735-6731-473a-b4f0-1f4a67aa7120	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	NCS HealthCare of KY, LLC dba Vangard Labs	647e17f5-a15a-4e77-922c-24a5db2118bc	2025-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Proficient Rx LP	cece294b-c414-4832-a8a2-22fb66aabda9	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	NuCare Pharmaceuticals,Inc.	5631bb72-798a-6efc-e054-00144ff8d46c	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	NuCare Pharmaceuticals,Inc.	78994632-74b3-951c-e053-2a91aa0ac1c8	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Bryant Ranch Prepack	7553d708-22a0-44ea-b907-7a86f2657f4c	2024-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Bryant Ranch Prepack	493a5946-e750-4500-afd1-8f3fdc1d420e	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001
Fluoxetine	FLUOXETINE	Teva Pharmaceuticals USA, Inc.	06d71a33-5578-4012-b11d-764f45bc1e6a	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076001 application number: ANDA076001

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310384	FLUoxetine 10 MG Oral Capsule	PSN	1a2a5194-b793-4c62-a177-040dad38526b	6
310384	fluoxetine 10 MG Oral Capsule	SCD	1a2a5194-b793-4c62-a177-040dad38526b	6
310384	fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule	SY	1a2a5194-b793-4c62-a177-040dad38526b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-233-30	63187023330	30 CAPSULE in 1 BOTTLE (63187-233-30)	30 capsule	2026-05-22		0		Current
63187-233-90	63187023390	90 CAPSULE in 1 BOTTLE (63187-233-90)	90 capsule	2002-01-29	0000-00-00	No	No	Current