FDA.reportPublic FDA data

NDC 0603-7634-01 - Orsythia

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0603-7634
Requested NDC
0603-7634-01
Package NDCs from labels
0603-7634-01, 0603-7634-49, 0603-7634-17
Manufacturer
RPK Pharmaceuticals, Inc.
Effective date
2020-12-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Orsythia - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2020-12-24HUMAN PRESCRIPTION DRUG LABEL
Orsythia - A-S Medication SolutionsA-S Medication Solutions2017-11-22HUMAN PRESCRIPTION DRUG LABEL
Orsythia - Par Pharmaceutical | Patheon Inc. | Sharp CorporationPar Pharmaceutical | Patheon Inc. | Sharp Corporation2017-08-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-7634-01EA - Each0603-7634fa5bc3d5-ad77-4f4b-929e-bba11ebc326e12015-05-05
0603-7634-17EA - Each0603-7634035f719d-56eb-41f2-bc06-14580d2645b112012-07-24
0603-7634-49EA - Each0603-7634b2adc20b-f293-4420-a5d4-372bcb30f09b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1ORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9

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 7 of 18 · 341 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeconNORETHINDRONE AND ETHINYL ESTRADIOLMayne Pharma Inc.e80714f4-cdfe-4d60-a4e1-b8c7b184cc462025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AzuretteDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLMayne Pharma Inc.bff09a7b-aea6-460b-a263-44576e00f5102025-09-08Warnings, Adverse reactionsExact identifier
rxcui: 748797
Aubra EQLEVONORGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack5bebc7e2-d085-410c-bae1-7d758d3c20162025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
Drospirenone and Ethinyl EstradiolDROSPIRENONE AND ETHINYL ESTRADIOLNorthStar Rx LLCc88c3eb8-3bf5-4004-a7ab-7218cd2f91822025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AyunaLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limited2b54ce42-db64-46c3-a788-569e21f7ab062025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Aubra EQLEVONORGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC61207a91-8b3c-4231-b98f-3cb9f4a4be092025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
AfirmelleLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limiteddd6122cd-b7ba-4fe3-bde5-910882475b672025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
Chateal EQLEVONORGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC4c59652c-49a6-4eed-b557-9abd3ffac5412025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Low-OgestrelNORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.8755b020-d439-4ba2-a60b-6c57a15ece552025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LuteraLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.b91ad328-f2f4-4f7d-82d3-daaada95f5092025-07-28Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
LevoraLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.31679b9f-58c9-4bf1-8c2c-f5a216ff4cd32025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SRONYXLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.b0c1a495-4cd7-4664-8fe4-714812f53c712025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
JulieLEVONORGESTRELJulie Products Inc2e9784da-2186-a630-e063-6294a90a84932025-07-14WarningsExact identifier
unii: 5W7SIA7YZW
Hemorrhoid CreamHEMORRHOID CREAMHenan Shouerkang Health Industry Co., Ltd426c0602-63a5-104b-e063-6294a90ae9642025-07-07WarningsExact identifier
unii: H4N855PNZ1
LevonorgestrelLEVONORGESTRELOhm Laboratories Inc.f3f2a41a-a9af-4d63-81d8-33181d12af402025-07-04WarningsExact identifier
unii: 5W7SIA7YZW
Cyred EQDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack241fb1e2-c0da-47b8-b502-2cb17976d7c02025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
YazDROSPIRENONE AND ETHINYL ESTRADIOLBayer HealthCare Pharmaceuticals Inc.065f33e4-b587-4e66-b896-ca9ab7b7c8762025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AfterPillLEVONORGESTRELSyzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 068804d284ba4-9cd7-48e4-95b9-cd6d0367bfd12025-05-01WarningsExact identifier
unii: 5W7SIA7YZW
PostDay One-StepLEVONORGESTRELHome Health Brands, LLC01c8c95c-6fbe-4068-915d-74418a6bb5702025-04-23WarningsExact identifier
unii: 5W7SIA7YZW
LUIZZA 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed, LLC88d90f33-1034-4d27-034f-11d9c441c9e72025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.