Lyleq

Product NDC
53002-1793
11-digit product format
530021793
Labeler code
53002
Product ID
53002-1793_d15c3fd7-8e69-4ac1-ad6d-172c8b5e7bde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NORETHINDRONE
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA207304
Marketing category
ANDA
Marketing start
2016-09-23
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
c21bcd2e-ecbd-48e6-ab68-12cc12256c0fProduct name220190213
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
f6ac5560-6d3b-d281-41d2-adc50d283c20Product name320170228
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1793-1Lyleq1 in 1 PACKAGETABLET13
53002-1793-1Lyleq28 in 1 BLISTER PACKTABLET283
53002-1793-3Lyleq28 in 1 BLISTER PACKTABLET283
53002-1793-3Lyleq3 in 1 CARTONTABLET33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1793LYLEQ (NORETHINDRONE) TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 4 package rows20220421_04569279-6b8e-49cf-86d3-f4921ffd9967.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2397128{28 (norethindrone 0.35 MG Oral Tablet) } Pack [Lyleq 28 Day]BPCK04569279-6b8e-49cf-86d3-f4921ffd99673
748961{28 (norethindrone 0.35 MG Oral Tablet) } PackGPCK04569279-6b8e-49cf-86d3-f4921ffd99673
2397128Lyleq 28 Day PackPSN04569279-6b8e-49cf-86d3-f4921ffd99673
748961Noreth 0.35 MG (28) Oral Tablet 28 Day PackPSN04569279-6b8e-49cf-86d3-f4921ffd99673
198042norethindrone 0.35 MG Oral TabletPSN04569279-6b8e-49cf-86d3-f4921ffd99673
198042norethindrone 0.35 MG Oral TabletSCD04569279-6b8e-49cf-86d3-f4921ffd99673
2397128Lyleq 28 Day PackSY04569279-6b8e-49cf-86d3-f4921ffd99673

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1793-1530021793011 BLISTER PACK in 1 PACKAGE (53002-1793-1) > 28 TABLET in 1 BLISTER PACK1 blister pack2021-12-310000-00-00NoNoCurrent
53002-1793-3530021793033 BLISTER PACK in 1 CARTON (53002-1793-3) > 28 TABLET in 1 BLISTER PACK3 blister pack2021-12-310000-00-00NoNoCurrent