FDA.reportPublic FDA data

Orsythia

Product NDC
53002-3647
11-digit product format
530023647
Labeler code
53002
Product ID
53002-3647_43272706-a1fd-49d7-a6ae-de0f7d8a57a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levonorgestrel and Ethinyl Estradiol
Dosage form
KIT
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA201088
Marketing category
ANDA
Marketing start
2018-04-15
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53002-3647IInactivated by FDA2026-07-31
excluded packagepackage53002-364753002-3647-1IInactivated by FDA2026-07-31
excluded packagepackage53002-364753002-3647-3IInactivated by FDA2026-07-31
excluded packagepackage53002-364753002-3647-6IInactivated by FDA2026-07-31

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
A201088-001VIENVAETHINYL ESTRADIOL; LEVONORGESTREL0.02MG;0.1MGTABLET / ORAL-28AB12015-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201088-001AB1

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A201088-001VIENVA0.02MG;0.1MGTABLET / ORAL-28AB12015-05-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201088-001AB11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VIENVA TMLEVONORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsf6825c1a-ba78-47aa-9622-12e59517ab1a2026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201088
application number: ANDA201088
Vienva TMLEVONORGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack8b1b92f7-b736-436d-b06d-1fedeb9704082024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201088
application number: ANDA201088
VienvaLEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.58ea31df-f9cf-7d00-c2db-0529fb9a3e532024-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201088
application number: ANDA201088

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
53002-3647-12023-01-30C16284748780-1f386c649-9d2b-0266-e053-dadaa90a7c1aOrsythia ® (levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg Rx only
53002-3647-32023-01-30C16284748780-1f386c649-9d2b-0266-e053-dadaa90a7c1aOrsythia ® (levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg Rx only
53002-3647-62023-01-30C16284748780-1f386c649-9d2b-0266-e053-dadaa90a7c1aOrsythia ® (levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3647-1Orsythia1 in 1 BLISTER PACKKIT12
53002-3647-3Orsythia3 in 1 POUCHKIT32
53002-3647-3Orsythia1 in 1 BLISTER PACKKIT12
53002-3647-6Orsythia6 in 1 POUCHKIT62
53002-3647-6Orsythia1 in 1 BLISTER PACKKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3647ORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [RPK PHARMACEUTICALS, INC.]2Legacy NDC, 5 package rows20201226_0a2775d0-8ca1-457f-9fbe-096f03aedc79.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]BPCK0a2775d0-8ca1-457f-9fbe-096f03aedc792
748868{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK0a2775d0-8ca1-457f-9fbe-096f03aedc792
748868Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN0a2775d0-8ca1-457f-9fbe-096f03aedc792
748797inert 1 MG Oral TabletPSN0a2775d0-8ca1-457f-9fbe-096f03aedc792
242297levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral TabletPSN0a2775d0-8ca1-457f-9fbe-096f03aedc792
1428933Orsythia 28 Day PackPSN0a2775d0-8ca1-457f-9fbe-096f03aedc792
242297ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral TabletSCD0a2775d0-8ca1-457f-9fbe-096f03aedc792
748797inert ingredients 1 MG Oral TabletSCD0a2775d0-8ca1-457f-9fbe-096f03aedc792
1428933Orsythia 28 Day PackSY0a2775d0-8ca1-457f-9fbe-096f03aedc792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3647-1530023647011 KIT in 1 BLISTER PACK (53002-3647-1) 1 kit2019-01-010000-00-00NoNoCurrent
53002-3647-3530023647033 BLISTER PACK in 1 POUCH (53002-3647-3) > 1 KIT in 1 BLISTER PACK3 blister pack2019-01-010000-00-00NoNoCurrent
53002-3647-6530023647066 BLISTER PACK in 1 POUCH (53002-3647-6) > 1 KIT in 1 BLISTER PACK6 blister pack2019-01-010000-00-00NoNoCurrent