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 1 of 18 · 343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
LEVONORGESTRELLEVONORGESTRELYYBA CORP5a71b870-9a0a-7997-e063-6294a90a882c2026-09-01WarningsExact identifier
unii: 5W7SIA7YZW
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals, Inc.90240210-0bca-4a55-99dc-19f2b40d8e3f2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.58e85e02-93e7-42ba-b8f5-a36290c684232026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SLYNDDROSPIRENONEExeltis USA, Inc.db32bc55-f295-4d87-9dbb-0a2f45573dcf2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 748797
TyblumeLEVONORGESTREL AND ETHINYL ESTRADIOLExeltis USA, Inc.b2482d51-d606-4aaa-8af4-19e4fe2f88722026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 242297
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
IsibloomDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack4a8f278f-f505-4537-8deb-74e8927df8c62026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepacke0b07fb6-8dbd-4e5d-b589-5191a1dc02ae2026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLRedpharm Drug57d1d945-9fc9-4e79-e063-6294a90a738a2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.2385591b-70ee-0577-e063-6394a90a93572026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H4N855PNZ1
SheWiseLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA7be13a7e-b4ff-4fe1-82a6-f9914596d72a2026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA07567b80-d8a1-41c0-95e4-33afa584bbc42026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
Gwyn LoNORELGESTROMIN AND ETHINYL ESTRADIOLViatris Specialty LLCe92741f4-87fe-429f-b5b5-c558ed5f4fa92026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
TwirlaLEVONORGESTREL/ETHINYL ESTRADIOLAgile Therapeutics, Inc.bcaf8db0-1750-425d-b008-255b5e7a9cc62026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW
OPTION 2LEVONORGESTRELL. Perrigo Company7d7b9e61-9f3d-477d-b74d-b0cc725f9bba2026-06-25WarningsExact identifier
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

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