Lyleq

Product NDC: 50102-300
11-digit product format: 501020300
Labeler code: 50102
Product ID: 50102-300_ffb8f5fe-9e1a-4ca9-adc9-181093af01b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NORETHINDRONE
Dosage form: TABLET
Route: ORAL
Labeler: Afaxys Pharma, LLC
Application: ANDA207304
Marketing category: ANDA
Marketing start: 2016-09-23
Substance: NORETHINDRONE
Active strength: .35 mg/1
Pharmacologic classes: Progesterone Congeners [CS], Progestin [EPC]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207304-001	INCASSIA	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1		2016-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207304-001	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 2 · 41 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	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207304-001	INCASSIA	0.35MG	TABLET / ORAL-28	AB1	2016-09-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A207304-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207304-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207304-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207304-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207304-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207304-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207304-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207304-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207304-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207304-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207304-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207304-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207304-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207304-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207304-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207304-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207304-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207304-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207304-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207304-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207304-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207304-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207304-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207304-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207304-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207304-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207304-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207304-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207304-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207304-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207304-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207304-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207304-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207304-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207304-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207304-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207304-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207304-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207304-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207304-001	AB1	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lyleq
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NORETHINDRONE	.35 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T18F433X4S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198042	Internal RxNorm lookup
748961	Internal RxNorm lookup
2397128	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
c9f00a3e-c827-4066-bf85-079b3a20f25e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
859c4b0b-8cba-4f41-9afe-cc181a01fb62	Product name	2	20240215
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
833edb59-a012-45c2-aff5-2ed74b66fa59	Product name	1	20201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697	Product name	2	20200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424	Product name	6	20200716
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
c21bcd2e-ecbd-48e6-ab68-12cc12256c0f	Product name	2	20190213
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
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
f6ac5560-6d3b-d281-41d2-adc50d283c20	Product name	3	20170228
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
23ede539-308f-46e5-817b-41ef23af8d40	Product name	1	20150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4d	Product name	1	20150930
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50102-300-01	Lyleq	28 in 1 BLISTER PACK	TABLET	28	3
50102-300-11	Lyleq	1 in 1 PACKAGE	TABLET	1	3
50102-300-13	Lyleq	3 in 1 CARTON	TABLET	3	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50102-300-01	EA - Each	50102-300	0878ac19-e75b-4d0d-9c66-fd77bf43bd16	1	2021-02-05
50102-300-11	EA - Each	50102-300	d810e472-bcb5-4cc1-bf7b-6ef6a3c2c41b	1	2021-02-05
50102-300-13	EA - Each	50102-300	ee4b6b88-bf4a-4291-92dd-d04d1fb51b39	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50102-300	LYLEQ (NORETHINDRONE) TABLET [AFAXYS PHARMA, LLC]	3	Current NDC, Legacy NDC, 3 package rows	20230401_c9f00a3e-c827-4066-bf85-079b3a20f25e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lyleq	NORETHINDRONE	Afaxys Pharma, LLC	c9f00a3e-c827-4066-bf85-079b3a20f25e	2023-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207304 application number: ANDA207304 ndc (product): 50102-300
Incassia	NORETHINDRONE	Aurobindo Pharma Limited	0b87cef0-610c-469d-92ba-4007f4bc3878	2021-09-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207304 application number: ANDA207304

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T18F433X4S	NORETHINDRONE	68-22-4	NORETHINDRONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2397128	{28 (norethindrone 0.35 MG Oral Tablet) } Pack [Lyleq 28 Day]	BPCK	04569279-6b8e-49cf-86d3-f4921ffd9967	3
2397128	{28 (norethindrone 0.35 MG Oral Tablet) } Pack [Lyleq 28 Day]	BPCK	c9f00a3e-c827-4066-bf85-079b3a20f25e	3
748961	{28 (norethindrone 0.35 MG Oral Tablet) } Pack	GPCK	04569279-6b8e-49cf-86d3-f4921ffd9967	3
748961	{28 (norethindrone 0.35 MG Oral Tablet) } Pack	GPCK	c9f00a3e-c827-4066-bf85-079b3a20f25e	3
2397128	Lyleq 28 Day Pack	PSN	04569279-6b8e-49cf-86d3-f4921ffd9967	3
2397128	Lyleq 28 Day Pack	PSN	c9f00a3e-c827-4066-bf85-079b3a20f25e	3
748961	Noreth 0.35 MG (28) Oral Tablet 28 Day Pack	PSN	04569279-6b8e-49cf-86d3-f4921ffd9967	3
748961	Noreth 0.35 MG (28) Oral Tablet 28 Day Pack	PSN	c9f00a3e-c827-4066-bf85-079b3a20f25e	3
198042	norethindrone 0.35 MG Oral Tablet	PSN	04569279-6b8e-49cf-86d3-f4921ffd9967	3
198042	norethindrone 0.35 MG Oral Tablet	PSN	c9f00a3e-c827-4066-bf85-079b3a20f25e	3
198042	norethindrone 0.35 MG Oral Tablet	SCD	04569279-6b8e-49cf-86d3-f4921ffd9967	3
198042	norethindrone 0.35 MG Oral Tablet	SCD	c9f00a3e-c827-4066-bf85-079b3a20f25e	3
2397128	Lyleq 28 Day Pack	SY	04569279-6b8e-49cf-86d3-f4921ffd9967	3
2397128	Lyleq 28 Day Pack	SY	c9f00a3e-c827-4066-bf85-079b3a20f25e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50102-300-01	50102030001	28 in 1 BLISTER PACK						Historical
50102-300-11	50102030011	1 in 1 PACKAGE						Historical
50102-300-13	50102030013	3 PACKAGE in 1 CARTON (50102-300-13) / 1 BLISTER PACK in 1 PACKAGE (50102-300-11) / 28 TABLET in 1 BLISTER PACK (50102-300-01)	3 package	2016-09-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lyleq ® (Norethindrone Tablets USP, 0.35 mg) Rx only	Afaxys Pharma, LLC \| Aurobindo Pharma Limited	2023-03-27	Human Prescription Drug Label	3
Lyleq™ (Norethindrone Tablets USP, 0.35 mg) Rx only	RPK Pharmaceuticals, Inc.	2022-04-20	Human Prescription Drug Label	3