Orsythia

Product NDC
50090-1380
11-digit product format
500901380
Labeler code
50090
Product ID
50090-1380_d77c57ce-1de4-4e5e-a276-f2c6c797a27e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levonorgestrel and ethinyl estradiol
Dosage form
KIT
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077099
Marketing category
ANDA
Marketing start
2011-05-11
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct50090-1380IInactivated by FDA2026-08-03
excluded packagepackage50090-138050090-1380-0IInactivated by FDA2026-08-03

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-1380-0IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-1380-0IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-1380-0IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-1380-0IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-1380-0IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-1380-0IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-1380-0IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-1380-0IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-1380-0IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-1380-0IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-1380-0IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-1380-0IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-1380-0IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-1380-0IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-1380-0IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50090-1380-0IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50090-1380-0IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50090-1380-0IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50090-1380-0IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-1380-0IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-1380-0IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage50090-1380-0EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
A077099-001ORSYTHIAETHINYL ESTRADIOL; LEVONORGESTREL0.02MG;0.1MGTABLET / ORAL-282011-05-11

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 UTC2026-02A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-28AB12011-05-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-28AB12011-05-113f01610625f2…
2019-09-15 20:21 UTC2019-09A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-28AB12011-05-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-28AB12011-05-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077099-001ORSYTHIA0.02MG;0.1MGTABLET / ORAL-282011-05-11cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077099-001AB1174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077099-001AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A077099-001AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A077099-001AB11ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11Product name420250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
782f1593-b73e-4d35-8017-647969d714d8Product name420240805
1a545a57-aed5-4b6e-b1f9-a93c26d50effProduct name120230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689Product name520230627
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9Product name820200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6Product name820191120
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
f713a022-3e1c-4035-bc91-62131bc80b42Product name220190125
60ff9adc-7870-42ca-8836-514bd9732fa8Product name420181220
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
2d386545-84d1-e1e9-1402-7fc8962353e8Product name220170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8Product name420170608
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
741e98f2-ac6c-4d80-9ca8-c663c171ba1dProduct name120161121
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
cc765024-f257-4c67-b780-c356aadd6980Product name320150902
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
5a9b579b-8431-5b3a-2ba4-86556704f873Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d03a75af-b11b-673b-268b-318050d0b3bdProduct name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
e5ccd419-1745-560a-1e25-c6e3941c710aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1380-02020-01-31C16284748780-19d75b9d0-16b7-f424-e053-dadaa90a57ceORSYTHIA ® (LEVONORGESTREL (0.1 mg) AND ETHINYL ESTRADIOL (0.02 mg) TABLETS USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1380-0Orsythia1 in 1 KITKIT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1380-0EA - Each50090-1380fc523e12-0724-47b2-8c2b-37f5fdef770812018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1380ORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS]11Legacy NDC, 1 package rows20171212_5acb5f67-c6cc-4fd6-8702-92e2974023de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1428933{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Orsythia 28 Day]BPCK5acb5f67-c6cc-4fd6-8702-92e2974023de11
748868{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK5acb5f67-c6cc-4fd6-8702-92e2974023de11
748868Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN5acb5f67-c6cc-4fd6-8702-92e2974023de11
748797inert 1 MG Oral TabletPSN5acb5f67-c6cc-4fd6-8702-92e2974023de11
242297levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral TabletPSN5acb5f67-c6cc-4fd6-8702-92e2974023de11
1428933Orsythia 28 Day PackPSN5acb5f67-c6cc-4fd6-8702-92e2974023de11
242297ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral TabletSCD5acb5f67-c6cc-4fd6-8702-92e2974023de11
748797inert ingredients 1 MG Oral TabletSCD5acb5f67-c6cc-4fd6-8702-92e2974023de11
1428933Orsythia 28 Day PackSY5acb5f67-c6cc-4fd6-8702-92e2974023de11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-1380-0500901380001 in 1 KITHistorical