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 6 of 18 · 341 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tri-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLCb71a2b34-95bf-4430-83a0-1a4d1218ea3c2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Her StyleLEVONORGESTRELIngenus Pharmaceuticals, LLC6e631755-b7c5-4a3a-b46d-f66b4ceedb1c2025-12-05WarningsExact identifier
unii: 5W7SIA7YZW
PhilithNORETHINDRONE AND ETHINYL ESTRADIOL TABLETSNorthstar Rx LLC77b8d3ef-f3ac-4148-84f0-f6cb327c9f782025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 748797
New DayLEVONORGESTRELNorthstar Rx LLC9e8c96f6-ab51-4721-b276-1ca02a7125102025-12-05WarningsExact identifier
unii: 5W7SIA7YZW
ElinestNORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCaa7f4a83-71cf-4306-b0a1-01784f67bae22025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SETLAKINLEVONORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCb7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.35eb35e6-d9a0-4472-94ac-aa470ccba5672025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.a8955f3b-afc9-4ef0-8946-9c97ab5b2e052025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
My WayLEVONORGESTRELLupin Pharmaceuticals, Inc.3efec61d-e0a6-49c5-9b88-834db6d171fd2025-12-02WarningsExact identifier
unii: 5W7SIA7YZW
JBA Verestor Mega Fiber PowderVITAMIN C,VITAMIN E,INULIN,BANANA STEM EXTRACT,NATTOKINASE,HOUTTUYNIA CORDATA EXTRACT,RUTIN,BETA-CAROTENEAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticalse7b861da-3851-4a75-b707-4a427c938ee12025-11-28WarningsExact identifier
unii: H4N855PNZ1
Julie Morning After PillLEVONORGESTRELJulie Products Inc.40bb96f0-d5f1-1ec3-e063-6294a90a74b12025-11-26WarningsExact identifier
unii: 5W7SIA7YZW
VyfemlaNORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.175ce5c4-d332-4c97-a0b8-10821dc813ef2025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
JuleberDESOGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCde9a2d1b-15f6-453f-b36b-1c2a43c4918d2025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Julie Morning After PillLEVONORGESTRELJulie Products Inc.40bbad6f-0c54-e4ed-e063-6394a90af3ad2025-11-14WarningsExact identifier
unii: 5W7SIA7YZW
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLOrganon LLC55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d972025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Zovia 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETSMayne Pharma Inc.d0d2a9e9-e9ce-4a42-b429-5c1f9a5447952025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 748797
MirenaLEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.dcbd6aa2-b3fa-479a-a676-56ea742962fc2025-10-29Warnings, Adverse reactionsExact identifier
unii: 5W7SIA7YZW
KyleenaLEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.2e07c155-21e1-4781-9633-ce8bddd470802025-10-23Warnings, Adverse reactionsExact identifier
unii: 5W7SIA7YZW
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions524c7188-ee84-4d5c-a6ab-e7a5ae36e22b2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals Inc.1f8b9aad-f31f-4cda-861d-c08a977fc9232025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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