LYZA

Product NDC
50102-100
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50102-100-032023-01-30C16284748780-1f386c649-a411-0266-e053-dadaa90a7c1aLyza® Norethindrone Tablets USP, 0.35 mg
50102-100-482023-01-30C16284748780-1f386c649-a411-0266-e053-dadaa90a7c1aLyza® Norethindrone Tablets USP, 0.35 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50102-100-00LYZA28 in 1 BLISTER PACKTABLET2813
50102-100-01LYZA1 in 1 PACKAGETABLET113
50102-100-03LYZA03 in 1 CARTONTABLET0313
50102-100-10LYZA1 in 1 PACKAGETABLET113
50102-100-48LYZA48 in 1 CASETABLET4813

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50102-100LYZA (NORETHINDRONE) TABLET [AFAXYS PHARMA LLC]13Legacy NDC, 5 package rows20210128_fe2cb3eb-dcd0-470c-8cf0-78fda554b1f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1430383{28 (norethindrone 0.35 MG Oral Tablet) } Pack [Lyza]BPCKfe2cb3eb-dcd0-470c-8cf0-78fda554b1f713
748961{28 (norethindrone 0.35 MG Oral Tablet) } PackGPCKfe2cb3eb-dcd0-470c-8cf0-78fda554b1f713
1430383Lyza 28 Day PackPSNfe2cb3eb-dcd0-470c-8cf0-78fda554b1f713
748961Noreth 0.35 MG (28) Oral Tablet 28 Day PackPSNfe2cb3eb-dcd0-470c-8cf0-78fda554b1f713
198042norethindrone 0.35 MG Oral TabletPSNfe2cb3eb-dcd0-470c-8cf0-78fda554b1f713
198042norethindrone 0.35 MG Oral TabletSCDfe2cb3eb-dcd0-470c-8cf0-78fda554b1f713
1430383Lyza 28 Day PackSYfe2cb3eb-dcd0-470c-8cf0-78fda554b1f713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50102-100-005010201000028 in 1 BLISTER PACKHistorical
50102-100-01501020100011 in 1 PACKAGEHistorical
50102-100-03501020100033 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 package2017-07-010000-00-00NoNoCurrent
50102-100-10501020100101 in 1 PACKAGEHistorical
50102-100-485010201004848 PACKAGE in 1 CASE (50102-100-48) > 1 BLISTER PACK in 1 PACKAGE (50102-100-01) > 28 TABLET in 1 BLISTER PACK (50102-100-00) 48 package2013-07-180000-00-00NoNoCurrent