Falessa

Product NDC: 75854-601
11-digit product format: 758540601
Labeler code: 75854
Product ID: 75854-601_ce17984c-e5d8-4966-a606-f8b7f44b14af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levonorgestrel and Ethinyl Estradiol
Dosage form: KIT
Labeler: Avion Pharmaceuticals, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2014-02-17
Marketing end: 0000-00-00
Active strength: 0
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	75854-601		D	Discontinued by firm		2026-10-12
excluded package	package	75854-601	75854-601-01	D	Discontinued by firm		2026-10-12

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 · 44 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75854-601-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75854-601-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75854-601-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75854-601-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75854-601-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75854-601-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75854-601-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75854-601-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75854-601-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75854-601-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75854-601-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75854-601-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75854-601-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75854-601-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75854-601-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	75854-601-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	75854-601-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	75854-601-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	75854-601-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
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	75854-601-01	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	75854-601-01	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	75854-601-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11	Product name	4	20250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
8511fc19-172b-4e1f-90ec-2f09c85b16de	Product name	2	20250116
d9a998ac-31a9-4391-9054-c30e50912603	Product name	2	20240829
782f1593-b73e-4d35-8017-647969d714d8	Product name	4	20240805
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
1a545a57-aed5-4b6e-b1f9-a93c26d50eff	Product name	1	20230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50	Product name	3	20230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689	Product name	5	20230627
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	20210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697	Product name	2	20200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424	Product name	6	20200716
5956a0e2-c373-452c-bdcf-c93d354432ef	Product name	1	20200714
ca306105-d51c-4821-9ec1-8eec753d073d	Product name	1	20200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9	Product name	8	20200612
91c62db0-0295-c81c-d10a-0856c259edd6	Product name	2	20200428
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6	Product name	8	20191120
d32bc2b8-0bb7-2216-87aa-24639646e202	Product name	3	20190619
6dd982ab-2966-22ee-3b75-d225abb791aa	Product name	5	20190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4d	Product name	7	20190612
f92411e4-13dd-7baf-106e-9b3fcf758c39	Product name	4	20190502
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
f713a022-3e1c-4035-bc91-62131bc80b42	Product name	2	20190125
60ff9adc-7870-42ca-8836-514bd9732fa8	Product name	4	20181220
ddff2484-d547-4e6a-bacd-95eef7e31c64	Product name	2	20180807
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
79d5025d-8129-440a-b861-6df2d2661609	Product name	3	20180607
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
d871c48c-6b0b-4203-b55d-72ead21ea7ad	Product name	5	20180419
90854981-3820-4bc4-a1d3-666ec508941c	Product name	2	20180214
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
12434b90-2738-45d5-9e1b-55001e853273	Product name	2	20171122
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
2d386545-84d1-e1e9-1402-7fc8962353e8	Product name	2	20170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8	Product name	4	20170608
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
00606b81-6e33-4c38-9ca9-bd14bd74d84c	Product name	4	20170501
f4ce24e8-8632-4fad-9984-b693f985f80f	Product name	3	20170501
b17c5419-b38b-579f-10bc-8a4ce69fc044	Product name	5	20170316
120cc5ad-761c-444c-9e82-dec22f96dfe1	Product name	7	20161219
741e98f2-ac6c-4d80-9ca8-c663c171ba1d	Product name	1	20161121
01996782-abcb-4e6d-bcaf-4a23e6a95c0c	Product name	1	20160714
2aecf0b6-88a0-49e5-92e1-983c700c116c	Product name	1	20151222
61972742-5d4d-491d-a881-b6bc3a011577	Product name	1	20151113
cc765024-f257-4c67-b780-c356aadd6980	Product name	3	20150902
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5a9b579b-8431-5b3a-2ba4-86556704f873	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	Product name	1	20140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
d03a75af-b11b-673b-268b-318050d0b3bd	Product name	1	20140508
d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
e5ccd419-1745-560a-1e25-c6e3941c710a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75854-601-01	2020-01-31	C162847	48780-1	9d75b9d1-1563-f424-e053-dadaa90a57ce	Falessa Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75854-601-01	Falessa	2 in 1 BOX	KIT	2		5
75854-601-01	Falessa	1 in 1 CARTON	KIT	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75854-601-01	EA - Each	75854-601	8b626ee6-c02a-43c2-a061-c3e0a5a6fa19	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
FOLIC ACID	ACTIVE INGREDIENT	935E97BOY8	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
LEVONORGESTREL	ACTIVE INGREDIENT	5W7SIA7YZW	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
FOLIC ACID	ACTIVE MOIETY	935E97BOY8	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
LEVONORGESTREL	ACTIVE MOIETY	5W7SIA7YZW	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75854-601	FALESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]	5	Legacy NDC, 2 package rows	20141104_efde9da5-2a96-4d0d-903c-20862790a9db.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
75854-601-01	75854060101	2 in 1 BOX	Historical