ADDYI

Product NDC: 58604-214
Requested package NDC: 58604-214-30
11-digit product format: 586040214
Labeler code: 58604
Product ID: 58604-214_1d1d7ef0-7a05-41c3-849f-6f1778863a73
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: flibanserin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sprout Pharmaceuticals, Inc.
Application: NDA022526
Marketing category: NDA
Marketing start: 2015-08-18
Substance: FLIBANSERIN
Active strength: 100 mg/1
Pharmacologic classes: P-Glycoprotein 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 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
N022526-001	ADDYI	FLIBANSERIN	100MG	TABLET / ORAL		RLD, RS	2015-08-18

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022526-001	7151103	2028-05-09	U-1734		2015-09-14

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022526-001	I-983	2028-12-13

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	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022526-001	ADDYI	100MG	TABLET / ORAL	RLD, RS	2015-08-18	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 103 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022526-001	7151103	2028-05-09	U-1734		2015-09-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022526-001	7420057	2022-08-01		Drug substance, Drug product	2015-09-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022526-001	9468639	2022-10-16	U-1734		2016-11-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022526-001	7151103	2023-05-09	U-1734		2015-09-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022526-001	8227471	2023-05-09	U-1734		2015-09-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022526-001	7420057	2022-08-01		Drug substance, Drug product	2015-09-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022526-001	9468639	2022-10-16	U-1734		2016-11-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022526-001	7151103	2023-05-09	U-1734		2015-09-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022526-001	8227471	2023-05-09	U-1734		2015-09-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022526-001	7420057	2022-08-01		Drug substance, Drug product	2015-09-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022526-001	9468639	2022-10-16	U-1734		2016-11-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022526-001	7151103	2023-05-09	U-1734		2015-09-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022526-001	8227471	2023-05-09	U-1734		2015-09-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022526-001	7420057	2022-08-01		Drug substance, Drug product	2015-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022526-001	9468639	2022-10-16	U-1734		2016-11-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022526-001	7151103	2023-05-09	U-1734		2015-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022526-001	8227471	2023-05-09	U-1734		2015-09-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022526-001	7420057	2022-08-01		Drug substance, Drug product	2015-09-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022526-001	9468639	2022-10-16	U-1734		2016-11-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022526-001	7151103	2023-05-09	U-1734		2015-09-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022526-001	8227471	2023-05-09	U-1734		2015-09-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022526-001	7420057	2022-08-01		Drug substance, Drug product	2015-09-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022526-001	9468639	2022-10-16	U-1734		2016-11-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022526-001	7151103	2023-05-09	U-1734		2015-09-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022526-001	8227471	2023-05-09	U-1734		2015-09-14	`782e0a99824c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N022526-001	I-983	2028-12-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022526-001	I-983	2028-12-13	`caaa826d4ba7…`
2019-12-13 00:20 UTC	2019-12	N022526-001	NCE	2020-08-18	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022526-001	NCE	2020-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022526-001	NCE	2020-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022526-001	NCE	2020-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022526-001	NCE	2020-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022526-001	NCE	2020-08-18	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022526-001	I-983	2028-12-13	`a50c72e98297…`

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: ADDYI
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLIBANSERIN	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
37JK4STR6Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1665514	Internal RxNorm lookup
1666391	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
3819daf3-e935-2c53-c527-e1d57922f394	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
169d9b44-bad4-435d-b2c5-5bdead34d277	Product name	1	20150908

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58604-214-03	ADDYI	30 in 1 BOTTLE	TABLET, FILM COATED	30	15
58604-214-03	ADDYI	1 in 1 CARTON	TABLET, FILM COATED	1	15
58604-214-30	ADDYI	30 in 1 BOTTLE	TABLET, FILM COATED	30	15
58604-214-30	ADDYI	1 in 1 CARTON	TABLET, FILM COATED	1	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58604-214-30	EA - Each	58604-214	22a499c7-0e16-4915-aa99-774d4e0c683c	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Flibanserin	ACTIVE INGREDIENT	37JK4STR6Z	ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.]	3
Flibanserin	ACTIVE MOIETY	37JK4STR6Z	ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.]	3
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.]	3
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.]	3
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.]	3
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.]	3
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.]	3
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.]	3
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.]	3
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.]	3
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58604-214	ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.]	14	Current NDC, Legacy NDC, 4 package rows	20250321_3819daf3-e935-2c53-c527-e1d57922f394.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
ADDYI	FLIBANSERIN	Sprout Pharmaceuticals, Inc.	3819daf3-e935-2c53-c527-e1d57922f394	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022526 application number: NDA022526 ndc (package): 58604-214-30 ndc (product): 58604-214 ndc11 (package): 58604021430

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
37JK4STR6Z	FLIBANSERIN	167933-07-5	FLIBANSERIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1666391	addyi 100 MG Oral Tablet	PSN	3819daf3-e935-2c53-c527-e1d57922f394	15
1665514	flibanserin 100 MG Oral Tablet	PSN	3819daf3-e935-2c53-c527-e1d57922f394	15
1666391	flibanserin 100 MG Oral Tablet [Addyi]	SBD	3819daf3-e935-2c53-c527-e1d57922f394	15
1665514	flibanserin 100 MG Oral Tablet	SCD	3819daf3-e935-2c53-c527-e1d57922f394	15
1666391	Addyi 100 MG Oral Tablet	SY	3819daf3-e935-2c53-c527-e1d57922f394	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58604-214-30	58604021430	1 BOTTLE in 1 CARTON (58604-214-30) / 30 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2015-08-18	0000-00-00	No	No	Current