MonoNessa

Product NDC: 63187-054
11-digit product format: 631870054
Labeler code: 63187
Product ID: 63187-054_fa820c7d-710a-4c6b-b135-b87d4ce8778c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: norgestimate and ethinyl estradiol
Dosage form: KIT
Labeler: Proficient Rx LP
Application: NDA019653
Marketing category: NDA
Marketing start: 2003-01-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2020-12-31
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	63187-054		D	Discontinued by firm		2026-09-09
excluded package	package	63187-054	63187-054-28	D	Discontinued by firm		2026-09-09

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-054-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-054-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63187-054-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63187-054-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63187-054-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63187-054-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63187-054-28	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63187-054-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63187-054-28	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63187-054-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63187-054-28	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63187-054-28	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N019653-001	ORTHO CYCLEN-21	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21			1989-12-29
N019653-002	ORTHO CYCLEN-28	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28		RLD	1989-12-29

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG	TABLET / ORAL-21		1989-12-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG	TABLET / ORAL-28	RLD	1989-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG	TABLET / ORAL-21		1989-12-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG	TABLET / ORAL-28	RLD	1989-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG	TABLET / ORAL-21		1989-12-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG	TABLET / ORAL-28	RLD	1989-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`bb7c543d1eb4…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ethinyl estradiol	ACTIVE INGREDIENT	423D2T571U	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
norgestimate	ACTIVE INGREDIENT	C291HFX4DY	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
ethinyl estradiol	ACTIVE MOIETY	423D2T571U	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
norgestimate	ACTIVE MOIETY	C291HFX4DY	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONONESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-054-28	63187005428	6 BLISTER PACK in 1 CARTON (63187-054-28) > 1 KIT in 1 BLISTER PACK	6 blister pack	2018-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MonoNessa ® Tablets (norgestimate and ethinyl estradiol)	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3