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 2 of 18 · 341 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MONO-LINYAHNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions2ec8f18f-297c-405f-b191-a40767366bad2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
Free RadicalACETALDEHYDE, ALFALFA, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBYL PALMITATE, COBALTUM METALLICUM, CYSTEINUM, DIMETHYL GLYCINE, FERRUM METALLICUM, FUCUS VESICULOSUS, GABA (GAMMA AMINOBUTYRIC ACID), GLUTATHIONE, HORDEUM VULGARE, L-METHIONINE, MAGNESIUM FLUORATUM, MANGANESE GLUCONATE, NASTURTIUM AQUATICUM, ORYZA SATIVA, QUERCETIN, RAPHANUS SATIVUS, SELENIUM METALLICUM, SODIUM SELENITE, TRITICUM AESTIVUM, UBIDECARENONUM, VITAMIN E, ZINC PICOLINATE, ZINCUM METALLICUMDeseret Biologicals, Inc.2408a38a-9cdd-48c0-b76c-b72e4fe5d7192026-06-02WarningsExact identifier
unii: H4N855PNZ1
TurqozNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionse7a05138-91a5-4c66-a915-614576e0805a2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
KurveloLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.752f525e-1838-4058-9ab7-2c2d91f86dfd2026-05-20Boxed warning, WarningsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLApotex Corp.9187a357-e95d-4733-9627-f19522b863732026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LevonorgestrelLEVONORGESTRELRugby Laboratories076126e4-9d76-45cd-a86b-5b35c56b620a2026-05-13WarningsExact identifier
unii: 5W7SIA7YZW
Free RadicalALFALFA, ASCORBYL PALMITATE, CYSTEINUM, DIMETHYL GLYCINE, FUCUS VESICULOSUS, HORDEUM VULGARE, L-METHIONINE, MANGANESE GLUCONATE, NASTURTIUM AQUATICUM, QUERCETIN, RAPHANUS SATIVUS, SODIUM SELENITE, TRITICUM AESTIVUM, UBIDECARENONUM, ALPHA-LIPOICUM ACIDUM, GABA (GAMMA AMINOBUTYRIC ACID), ORYZA SATIVA, VITAMIN E, ZINC PICOLINATE, COBALTUM METALLICUM, FERRUM METALLICUM, GLUTATHIONE, MAGNESIUM FLUORATUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUMDeseret Biologicals, Inc.36060680-f0d2-44c3-82fa-649e6e9d454d2026-05-06WarningsExact identifier
unii: H4N855PNZ1
LEADER Emergency Contraceptive LevonorgestrelLEVONORGESTRELCardinal Health 110, LLC. DBA Leaderd1e33615-0a98-4223-833d-843c758d9db72026-05-06WarningsExact identifier
unii: 5W7SIA7YZW
My ChoiceLEVONORGESTRELOHM LABORATORIES INC500d9418-69a8-f4f3-e063-6394a90a9b662026-04-22WarningsExact identifier
unii: 5W7SIA7YZW
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Pharmaceuticals USA Inc.10fa1458-c8ed-4197-922a-1ba7271d2b022026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Lifesciences Limited7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a92026-04-16Exact identifier
unii: 423D2T571U
WeraNORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLC638e4f36-1a27-4220-8ec9-3fa9d9b36c112026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Dasetta 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLCda52e74a-1baf-4a33-a068-b491767003202026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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