NORLYROC

Product NDC
51660-127
11-digit product format
516600127
Labeler code
51660
Product ID
51660-127_cbe85544-dbbb-421c-ae7d-8d464f7a8f20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA202260
Marketing category
ANDA
Marketing start
2014-04-15
Marketing end
0000-00-00
Substance
NORETHINDRONE
Active strength
0 mg/1
Pharmacologic classes
Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
51660-127-862019-11-27C16284748780-19855e2a2-514e-60a7-e053-dbdaa90a05bdNORLYROC ™ (norethindrone) tablets USP, 0.35 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-127-86NORLYROC1 in 1 CARTONTABLET, FILM COATED12
51660-127-86NORLYROC28 in 1 BLISTER PACKTABLET, FILM COATED282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-127-86EA - Each51660-1275806a249-b706-454c-b2fa-4b4d43c6d47812014-08-01

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-127NORLYROC (NORETHINDRONE) TABLET, FILM COATED [OHM LABORATORIES INC.]2Legacy NDC, 2 package rows20140415_97fcc28a-7e00-4ce4-9976-bcb90e3dba64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1495092{28 (norethindrone 0.35 MG Oral Tablet) } Pack [Norlyroc 28 Day]BPCK97fcc28a-7e00-4ce4-9976-bcb90e3dba642
748961{28 (norethindrone 0.35 MG Oral Tablet) } PackGPCK97fcc28a-7e00-4ce4-9976-bcb90e3dba642
748961Noreth 0.35 MG (28) Oral Tablet 28 Day PackPSN97fcc28a-7e00-4ce4-9976-bcb90e3dba642
198042norethindrone 0.35 MG Oral TabletPSN97fcc28a-7e00-4ce4-9976-bcb90e3dba642
1495092Norlyroc 28 Day PackPSN97fcc28a-7e00-4ce4-9976-bcb90e3dba642
198042norethindrone 0.35 MG Oral TabletSCD97fcc28a-7e00-4ce4-9976-bcb90e3dba642
1495092Norlyroc 28 Day PackSY97fcc28a-7e00-4ce4-9976-bcb90e3dba642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51660-127-86516600127861 in 1 CARTONHistorical