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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51660-127IInactivated by FDA2026-08-11
excluded packagepackage51660-12751660-127-86IInactivated by FDA2026-08-11

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51660-127-86d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51660-127-86f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51660-127-862ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51660-127-86a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51660-127-86cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51660-127-86cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51660-127-86302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51660-127-86ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51660-127-860efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51660-127-86ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51660-127-86367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51660-127-86557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51660-127-868af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51660-127-86834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51660-127-861332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51660-127-86fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51660-127-8686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51660-127-86bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51660-127-868dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51660-127-86e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51660-127-869bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51660-127-86110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202260-001NORETHINDRONENORETHINDRONE0.35MGTABLET / ORAL-282013-08-01

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-013f01610625f2…
2019-09-15 20:21 UTC2019-09A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202260-001NORETHINDRONE0.35MGTABLET / ORAL-282013-08-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202260-001NORETHINDRONE0.35MGTABLET / ORAL-28AB12013-08-01cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202260-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202260-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202260-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202260-001AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202260-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202260-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202260-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A202260-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202260-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202260-001AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202260-001AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A202260-001AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A202260-001AB11ea99ee380514…
2022-09-29 23:25 UTC2022-09A202260-001AB11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202260-001AB11cb3db0bc1861…

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