VIORELE

Product NDC
50090-1395
11-digit product format
500901395
Labeler code
50090
Product ID
50090-1395_fb1ff52e-d5ff-4ef2-9d1e-7dab6b047318
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol
Dosage form
KIT
Labeler
A-S Medication Solutions
Application
ANDA091346
Marketing category
ANDA
Marketing start
2012-04-04
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct50090-1395EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage50090-139550090-1395-0EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…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
A091346-001VIORELEDESOGESTREL; ETHINYL ESTRADIOL0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A091346-001AB

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 UTC2026-02A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-023f01610625f2…
2019-09-15 20:21 UTC2019-09A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091346-001VIORELE0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28AB2012-04-02cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091346-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091346-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091346-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091346-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091346-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091346-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091346-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091346-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091346-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091346-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091346-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091346-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091346-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091346-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091346-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091346-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091346-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091346-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091346-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091346-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091346-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091346-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091346-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091346-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091346-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091346-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091346-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091346-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091346-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091346-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091346-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091346-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091346-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091346-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091346-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091346-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091346-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091346-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091346-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091346-001AB1cb3db0bc1861…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VIORELEDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLA-S Medication Solutions6422dcc3-959a-4590-9ca8-9dcb58e682532026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091346
application number: ANDA091346
ndc (product): 50090-1395
VIORELEDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA39988aa6-8f68-40e8-9bdd-c40a3bdaad612026-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091346
application number: ANDA091346

Additional Listing Data#

Finished product
Yes
Brand name base
VIORELE
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
248310Internal RxNorm lookup
249357Internal RxNorm lookup
748797Internal RxNorm lookup
759743Internal RxNorm lookup
1252016Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6422dcc3-959a-4590-9ca8-9dcb58e68253Available on FDA.report

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
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
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1395-0VIORELE1 in 1 KITKIT116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1395-0EA - Each50090-1395d358d236-1a0d-4c6d-bb6a-c7a9ca3cab6d12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1395VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 1 package rows20240516_6422dcc3-959a-4590-9ca8-9dcb58e68253.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1252016{21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } Pack [Viorele 28 Day]BPCK6422dcc3-959a-4590-9ca8-9dcb58e6825316
759743{21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } PackGPCK6422dcc3-959a-4590-9ca8-9dcb58e6825316
759743Desogest-Eth estra 0.15-0.02 MG (21) Oral Tablet / Eth estra 0.01 MG (5) Oral Tablet / Inert 1 MG (2) Oral Tablet 28 Day PackPSN6422dcc3-959a-4590-9ca8-9dcb58e6825316
249357desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral TabletPSN6422dcc3-959a-4590-9ca8-9dcb58e6825316
248310ethinyl estradiol 0.01 MG Oral TabletPSN6422dcc3-959a-4590-9ca8-9dcb58e6825316
748797inert 1 MG Oral TabletPSN6422dcc3-959a-4590-9ca8-9dcb58e6825316
1252016VIORELE 28 Day PackPSN6422dcc3-959a-4590-9ca8-9dcb58e6825316
249357desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral TabletSCD6422dcc3-959a-4590-9ca8-9dcb58e6825316
248310ethinyl estradiol 0.01 MG Oral TabletSCD6422dcc3-959a-4590-9ca8-9dcb58e6825316
748797inert ingredients 1 MG Oral TabletSCD6422dcc3-959a-4590-9ca8-9dcb58e6825316
248310ethinyl estradiol 10 MCG Oral TabletSY6422dcc3-959a-4590-9ca8-9dcb58e6825316
1252016Viorele 28 Day PackSY6422dcc3-959a-4590-9ca8-9dcb58e6825316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1395-0500901395001 KIT in 1 KIT (50090-1395-0) 1 kit2014-11-280000-00-00NoNoCurrent