FDA.reportPublic FDA data

NDC 68462-504-79 - Hailey 1.5/30

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
68462-504
Requested NDC
68462-504-79
Package NDCs from labels
68462-504-79, 68462-504-81
Manufacturer
Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited
Effective date
2026-01-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hailey ® 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP)Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2026-01-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-504-79Hailey 1.5/301 in 1 POUCHTABLET19
68462-504-79Hailey 1.5/3021 in 1 BLISTER PACKTABLET219
68462-504-81Hailey 1.5/303 in 1 CARTONTABLET39

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-504HAILEY 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [GLENMARK PHARMACEUTICALS INC., USA]8Current NDC, Legacy NDC, 3 package rows20240612_021df70a-0c37-4237-a2f7-2597ff6d41f5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-504-79EA - Each68462-504e3a985a8-5580-4522-ae5e-d04a25944c9112019-09-05
68462-504-81EA - Each68462-504130f517b-af28-4ae1-ad38-004a57aec00112019-09-05

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 4 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOPREEZAESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals NY LLC966ac064-9eb7-4d15-b271-a7880ed1e79a2025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
EluRyngETONOGESTREL AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLCc6c8512d-b258-4be5-8c2f-0f1893f198b92025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norethindrone AcetateNORETHINDRONE ACETATEGolden State Medical Supply, Inc.2bb29135-6e9b-a9e2-e063-6394a90ae9e42025-01-14Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
A-5SUCROSEDNA Labs, Inc.8e63f697-26c1-4518-acd3-5ea72cfa27f72025-01-09WarningsExact identifier
unii: C151H8M554
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.adfee6ce-05b0-4955-bf5f-9612b8db4c782024-12-26WarningsExact identifier
unii: C151H8M554
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLProficient Rx LP56e91ad4-f31b-494d-9e75-6dd4f396779c2024-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
FocusADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUMDeseret Biologicals, Inc.e014e6b6-a07a-4170-b9af-f477da71597d2024-11-13WarningsExact identifier
unii: C151H8M554
Thyroid TonicACACIA ARABICA, OLEUM OLEA EUROPAEA, SESAME OIL, FUCUS VESICULOSUS 3X, IODIUM, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAGE OIL, CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), HYDROFLUORICUM ACIDUMEnergique, Inc.aeca8e0e-12e6-44d0-a709-401d137f7cf32024-10-31WarningsExact identifier
unii: 5C5403N26O
Norethindrone AcetateNORETHINDRONEAmneal Pharmaceuticals LLC64cb920c-36e8-4d62-9d08-3ddf3989d3132024-10-30Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
LactistatARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, GRAPHITES, HYDROFLUORICUM ACIDUM, LACHESIS MUTUS, LACTICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SACCHARUM OFFICINALEEnergique, Inc.8dcc4a3a-9f21-4a77-ae42-b2c8283a076a2024-10-28WarningsExact identifier
unii: C151H8M554
Grain and Seed AntigensBAMBOO, BARLEY, CORN, COTTON SEED, FLAX SEED (LINUM USITATISSIMUM), MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SAFFLOWER, SESAME, SORGHUM, SOY BEAN, SUGARCANE, SUNFLOWER (HELIANTHUS ANNUUS), WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUREnergique, Inc.a028eaea-76ef-45db-80e1-d7b4a0655d5e2024-10-25WarningsExact identifier
unii: C151H8M554
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.cb1566a4-92d4-4f1a-9211-f0c538a83c272024-09-27WarningsExact identifier
unii: C151H8M554
PMS ReliefAGNUS CASTUS, AURUM SULPHURATUM, CANDIDA ALBICANS, CIMICIFUGA RACEMOSA, COCCULUS INDICUS, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, ELAPS CORALLINUS, FOLLICULINUM, HYPOTHALAMUS SUIS, KALI CARBONICUM, LAC CANINUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, PULSATILLA (PRATENSIS), SACCHARUM OFFICINALE, STANNUM METALLICUM, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Deseret Biologicals, Inc.f03d8463-0a6d-4577-8fba-9cba246d3d452024-09-23WarningsExact identifier
unii: C151H8M554
ABIGALE LOESTRADIOL AND NORETHINDRONE ACETATEXiromed LLCdf013d36-de10-0607-7e12-95ed43bf7ee92024-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
FocusGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, IODIUM, PHOSPHORUS, SARCOLACTICUM ACID, SACCHARUM OFFICINALE, ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, SILICEA, ADRENALINUM, AMBRA GRISEA, CARBONEUM SULPHURATUM, TARENTULA HISPANA, AETHUSA CYNAPIUM, BARYTA CARBONICA, HELLEBORUS NIGER, VERATRUM ALBUM, CANDIDA ALBICANS, HYOSCYAMUS NIGERDeseret Biologicals, Inc.e77857b8-be67-4041-8c8d-9772f17c6d062024-09-11WarningsExact identifier
unii: C151H8M554
PMS ReliefAGNUS CASTUS, CIMICIFUGA RACEMOSA, KALI CARBONICUM, LYCOPODIUM CLAVATUM, SACCHARUM OFFICINALE, THYROIDINUM (BOVINE), HYPOTHALAMUS SUIS, ARISTOLOCHIA CLEMATITIS, FOLLICULINUM, AURUM SULPHURATUM, CANDIDA ALBICANS, COCCULUS INDICUS, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, ELAPS CORALLINUS, LAC CANINUM, LACHESIS MUTUS, MAGNESIA CARBONICA, PULSATILLA (PRATENSIS), STANNUM METALLICUMDeseret Biologicals, Inc.ca073beb-330d-406c-9bf5-196a89f3ab582024-09-11WarningsExact identifier
unii: C151H8M554
GallifreyNORETHINDRONE ACETATEXiromed LLC26130af6-221b-2349-81b6-0c0132d6e5242024-08-31Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
FEIRZA 1.5/30 TMNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1.5 MG/30 MCG AND FERROUS FUMARATE TABLETS, 75 MGXiromed LLCdd18e808-bb80-8182-bf7b-8e6d5763570d2024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
Etonogestrel and Ethinyl Estradiol Vaginal RingETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RINGNorthstar Rx LLC1488f5ae-3b34-fcd7-6049-215929b1d3242024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
EnilloRingETONOGESTREL AND ETHINYL ESTRADIOL VAGINALXiromed, LLC85a126f6-d3e0-9e12-73f9-6176ba36f58b2024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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