LYZA

Product NDC: 50102-100
Requested package NDC: 50102-100-03
11-digit product format: 501020100
Labeler code: 50102
Product ID: 50102-100_8382cbc8-a13d-4c17-a076-d878690cb873
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: norethindrone
Dosage form: TABLET
Route: ORAL
Labeler: Afaxys Pharma LLC
Application: ANDA200980
Marketing category: ANDA
Marketing start: 2013-06-24
Marketing end: 0000-00-00
Substance: NORETHINDRONE
Active strength: 0 mg/1
Pharmacologic classes: Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50102-100	50102-100-03	I	Inactivated by FDA		2026-08-11

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A200980-001	NORETHINDRONE	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200980-001	AB2

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200980-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB2	RS	2013-06-12	`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	A200980-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200980-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200980-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200980-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200980-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200980-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200980-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200980-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200980-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200980-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200980-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200980-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200980-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200980-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200980-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200980-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200980-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200980-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200980-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200980-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200980-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200980-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200980-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200980-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200980-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200980-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200980-001	AB2	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200980-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200980-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200980-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200980-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200980-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200980-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200980-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200980-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200980-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200980-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200980-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200980-001	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200980-001	AB2	1	`cb3db0bc1861…`

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50102-100-03	2023-01-30	C162847	48780-1	f386c649-a411-0266-e053-dadaa90a7c1a	Lyza® Norethindrone Tablets USP, 0.35 mg
50102-100-48	2023-01-30	C162847	48780-1	f386c649-a411-0266-e053-dadaa90a7c1a	Lyza® Norethindrone Tablets USP, 0.35 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50102-100-00	LYZA	28 in 1 BLISTER PACK	TABLET	28	13
50102-100-01	LYZA	1 in 1 PACKAGE	TABLET	1	13
50102-100-03	LYZA	03 in 1 CARTON	TABLET	03	13
50102-100-10	LYZA	1 in 1 PACKAGE	TABLET	1	13
50102-100-48	LYZA	48 in 1 CASE	TABLET	48	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50102-100-01	EA - Each	50102-100	2e83f27d-1c30-46f3-84cd-876b7fde59f0	1	2013-08-02
50102-100-03	EA - Each	50102-100	bc553cd9-9974-481c-9c5d-aab9d7e94911	1	2017-04-05
50102-100-10	EA - Each	50102-100	a6286c6e-7dfb-4afa-a076-3e55e224ae8f	1	2017-08-11
50102-100-48	EA - Each	50102-100	b2f9741e-ee53-47bc-8aad-bd39ed58901e	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NORETHINDRONE	ACTIVE INGREDIENT	T18F433X4S	LYZA (NORETHINDRONE) TABLET [AFAXYS INC.]	6
NORETHINDRONE	ACTIVE MOIETY	T18F433X4S	LYZA (NORETHINDRONE) TABLET [AFAXYS INC.]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LYZA (NORETHINDRONE) TABLET [AFAXYS INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LYZA (NORETHINDRONE) TABLET [AFAXYS INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LYZA (NORETHINDRONE) TABLET [AFAXYS INC.]	6
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	LYZA (NORETHINDRONE) TABLET [AFAXYS INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LYZA (NORETHINDRONE) TABLET [AFAXYS INC.]	6
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LYZA (NORETHINDRONE) TABLET [AFAXYS INC.]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LYZA (NORETHINDRONE) TABLET [AFAXYS INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LYZA (NORETHINDRONE) TABLET [AFAXYS INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LYZA (NORETHINDRONE) TABLET [AFAXYS INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50102-100	LYZA (NORETHINDRONE) TABLET [AFAXYS PHARMA LLC]	13	Legacy NDC, 5 package rows	20210128_fe2cb3eb-dcd0-470c-8cf0-78fda554b1f7.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
MELEYA	NORETHINDRONE	Xiromed LLC	534c5717-382c-4109-3208-e21b32e4c4c9	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200980 application number: ANDA200980

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
1430383	{28 (norethindrone 0.35 MG Oral Tablet) } Pack [Lyza]	BPCK	fe2cb3eb-dcd0-470c-8cf0-78fda554b1f7	13
748961	{28 (norethindrone 0.35 MG Oral Tablet) } Pack	GPCK	fe2cb3eb-dcd0-470c-8cf0-78fda554b1f7	13
1430383	Lyza 28 Day Pack	PSN	fe2cb3eb-dcd0-470c-8cf0-78fda554b1f7	13
748961	Noreth 0.35 MG (28) Oral Tablet 28 Day Pack	PSN	fe2cb3eb-dcd0-470c-8cf0-78fda554b1f7	13
198042	norethindrone 0.35 MG Oral Tablet	PSN	fe2cb3eb-dcd0-470c-8cf0-78fda554b1f7	13
198042	norethindrone 0.35 MG Oral Tablet	SCD	fe2cb3eb-dcd0-470c-8cf0-78fda554b1f7	13
1430383	Lyza 28 Day Pack	SY	fe2cb3eb-dcd0-470c-8cf0-78fda554b1f7	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50102-100-03	50102010003	3 PACKAGE in 1 CARTON (50102-100-03) > 1 BLISTER PACK in 1 PACKAGE (50102-100-10) > 28 TABLET in 1 BLISTER PACK (50102-100-00)	3 package	2017-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lyza® Norethindrone Tablets USP, 0.35 mg	Afaxys Pharma LLC \| Mylan Laboratories Limited	2021-01-25	HUMAN PRESCRIPTION DRUG LABEL	13
Lyza® Norethindrone Tablets USP, 0.35 mg	RPK Pharmaceuticals, Inc.	2020-12-15	HUMAN PRESCRIPTION DRUG LABEL	3