FDA.reportPublic FDA data

NDC 70700-810 - Volnea

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
70700-810
Manufacturer
RPK Pharmaceuticals, Inc.
Effective date
2023-09-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Volnea - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-09-11HUMAN PRESCRIPTION DRUG LABEL
Volnea - Xiromed, LLC. | XIROMED PHARMA ESPANA, S.L.Xiromed, LLC. | XIROMED PHARMA ESPANA, S.L.2023-02-25HUMAN PRESCRIPTION DRUG LABEL

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 137 of 149 · 2,974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thinksport Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC77b63c0b-353b-4f5f-95c7-6f7eeab814712023-05-30WarningsExact identifier
unii: 15FIX9V2JP
Think Kids Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC25c59820-a08d-4abe-87ae-a787ac8b2ac22023-05-30WarningsExact identifier
unii: 15FIX9V2JP
Lo SimpesseLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLAurobindo Pharma Limited74d998ca-7b30-4023-928f-a0f0551992e62023-05-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 248310
YasminDROSPIRENONE AND ETHINYL ESTRADIOLBayer HealthCare Pharmaceuticals Inc.d7ea6a60-5a56-4f81-b206-9b27b7e588752023-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NextstellisDROSPIRENONE AND ESTETROLMayne Pharmac5270073-d083-4109-ae4b-156986175e0a2023-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-VyLibra LoNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLCbd51a08e-cd45-4315-9bca-41794450ef162023-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
CryselleNORGESTREL AND ETHINYL ESTRADIOLProficient Rx LP9c4fac8e-8744-4378-80af-7887de955a512023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.ada28708-ab65-4c07-a695-9141c5ce26bc2023-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 248310
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: ETJ7Z6XBU4
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: ETJ7Z6XBU4
Levonorgetsrel and Ethinyl EstradiolLEVONORGETSREL AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.b04e1404-6eee-48f3-a51e-66de3fc95b602023-04-01Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions6ae97238-28cf-4bc9-a4ba-1e2bf4e3c6002023-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SiliceaSILICON DIOXIDEBoiron86d34721-7dfc-bf91-e053-2991aa0a70ae2023-03-27Exact identifier
unii: ETJ7Z6XBU4
NS SupportBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS SUIS, PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM,Dr. Donna Restivo DC807fd9cf-13d1-4173-a6da-180f89b67cf22023-03-15WarningsExact identifier
unii: ETJ7Z6XBU4
ALTAVERALEVONORGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepackc607816d-0da9-4960-9723-69f28aa3f2f22023-03-02Boxed warningExact identifier
rxcui: 748797
VolneaDESOGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.d7f3a118-4a1a-786e-c1db-01a0c2f2189d2023-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202689
ndc (package): 70700-122-84
ndc (package): 70700-122-85
ndc (product): 70700-122
rxcui: 748797
rxcui: 759743
rxcui: 2001756
rxcui: 249357
rxcui: 248310
spl id: a76528bf-413e-fde6-6b5c-6bb35a1b63d8
spl set id: d7f3a118-4a1a-786e-c1db-01a0c2f2189d
KurveloLEVONORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions51e4270a-1b91-4ff8-9a50-ffe49204b6b42023-02-21Boxed warning, WarningsExact identifier
rxcui: 748797
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.d29af0e7-0d04-47e3-9a50-d99c7e14b44d2023-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d395ec-3c3b-5e5f-e053-2a91aa0a3f9c2023-02-20Exact identifier
unii: ETJ7Z6XBU4
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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