FDA.reportPublic FDA data

NDC 68462-309-84 - Norgestimate and Ethinyl Estradiol

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
68462-309
Requested NDC
68462-309-84
Package NDCs from labels
68462-309-84, 68462-309-29
Manufacturer
A-S Medication Solutions
Effective date
2026-03-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Norgestimate and Ethinyl Estradiol - A-S Medication SolutionsA-S Medication Solutions2026-03-03HUMAN PRESCRIPTION DRUG LABEL
Norgestimate and Ethinyl Estradiol - Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2026-02-06HUMAN PRESCRIPTION DRUG LABEL
Norgestimate and Ethinyl Estradiol - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL
Norgestimate and Ethinyl Estradiol - A-S Medication SolutionsA-S Medication Solutions2021-03-01HUMAN PRESCRIPTION DRUG LABEL
NORGESTIMATE - Glenmark Generics Inc., USA | Glenmark Generics LimitedGlenmark Generics Inc., USA | Glenmark Generics Limited2012-04-13HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-309-29Norgestimate and Ethinyl Estradiol3 in 1 CARTONKIT317
68462-309-84Norgestimate and Ethinyl Estradiol1 in 1 BLISTER PACKKIT117
68462-309-29Norgestimate and Ethinyl Estradiol3 in 1 CARTONKIT35
68462-309-84Norgestimate and Ethinyl Estradiol1 in 1 BLISTER PACKKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-309NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]14Current NDC, Legacy NDC, 2 package rows20230807_8b247e46-203e-4f5b-b5a7-cbd57341c735.zip
68462-309NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5Current NDC, Legacy NDC, 2 package rows20120413_beabee48-1912-47bf-a9b5-d5c426c4fcc2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-309-29EA - Each68462-309a21653d2-bcd2-4d67-b1eb-f518c8c5e3c612012-07-24
68462-309-84EA - Each68462-3092b31643c-2081-4343-86ea-abe8ed172c8312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
NORGESTIMATEACTIVE MOIETYC291HFX4DYNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
TALCINACTIVE INGREDIENT7SEV7J4R1UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
NORGESTIMATEACTIVE MOIETYC291HFX4DYNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
POVIDONEINACTIVE INGREDIENTFZ989GH94ENORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
TALCINACTIVE INGREDIENT7SEV7J4R1UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5

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 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
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
rxcui: 749860
rxcui: 240128
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Drainage-ToneCALCAREA IODATA, CAPSICUM ANNUUM, COENZYME A, ECHINACEA ANGUSTIFOLIA, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, NADIDUM, NITRICUM ACIDUM, OLEUM MORRHUAE, PETROSELINUM SATIVUM, PHYTOLACCA DECANDRA, SCROPHULARIA NODOSA, SILICEA, SINAPIS ALBA, THUJA OCCIDENTALIS.Energetix Corporation296b455e-27c5-4f6e-929d-c4ee75b7fb0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmapathGELSEMIUM, GINKGO, GLYCYRRHIZA, HYDROCOTYLE, HYPOTHALAMUS, PETROSELINUM, PITUITARUM POSTERIUM, PYRIDOXINUM HYDROCHLORICUM, SENNA, SILICEAEnergetix Corporation3c4e2867-4d75-416b-9f3d-e6e500e46f6f2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph-Tone IIAESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC.Energetix Corporationc46aa8d3-4aa5-4e07-be3d-d71abc5e24072026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph-Tone IIIADENOSINUM CYCLOPHOSPHORICUM, ARNICA, BOLDO, CALC IOD, CALENDULA, CARTILAGO SUIS, CEANOTHUS, COENZYME A, ECHINACEA, HAMAMELIS, HEPAR SULPH CALC, HYPOTHALAMUS, NADIDUM, NAJA, NAT SULPHURICUM, PHASEOLUS, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PYROGENIUM, SILICEA, SULPHUR, THUJA OCC, THYROIDINUM, VISCUMEnergetix Corporation4c9ae54c-ce7d-4276-add7-2922a8f0e3102026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Vac-ChordALUMINA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BOLDO, CALCAREA CARBONICA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA, HYDRASTIS CANADENSIS, LECITHIN, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MORBILLINUM, PERTUSSINUM, PHYTOLACCA DECANDRA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, THYROIDINUM.Energetix Corporation880ea1e6-8d4d-486e-9a8f-9d3158a996672026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Thyro-ChordHOMEOPATHIC LIQUIDEnergetix Corporation6655b504-dfa8-46df-9d3a-b7fa4078207e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Para-ChordHOMEOPATHIC LIQUIDEnergetix Corporation9f8f646e-634a-47ff-b208-b2249d685e552026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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