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 3 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions524c7188-ee84-4d5c-a6ab-e7a5ae36e22b2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norethindrone AcetateNORETHINDRONEAvKARE827c7ef1-a8b7-d0c4-b062-c5154b331a352025-09-17Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
MyfembreeRELUGOLIX, ESTRADIOL HEMIHYDRATE, AND NORETHINDRONE ACETATESumitomo Pharma America, Incfc3feb73-cc84-43a8-aa32-b262460495e82025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: C151H8M554
Microgestin 1.5/30NORETHINDRONE ACETATE/ETHINYL ESTRADIOLMayne Pharma Inc.9f49a476-596c-46e1-b67b-d3d40de842162025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
rxcui: 1359028
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: C151H8M554
BLISOVI FE 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.a0ba9371-46c5-4291-8409-491911e255ab2025-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
ShameADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALISDeseret Biologicals, Inc.090e4a23-3e1b-4b0c-a0cc-0172b05f7b642025-05-07WarningsExact identifier
unii: C151H8M554
JUNEL FE 28 DAYNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEA-S Medication Solutions0428e1fd-3e1b-44fe-83fe-cf6be09155522025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
LUIZZA 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed, LLC88d90f33-1034-4d27-034f-11d9c441c9e72025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
DolishaleLEVONORGESTREL AND ETHINYL ESTRADIOLIngenus Pharmaceuticals, LLC036a15be-8c2e-4f65-b5dc-f333e2994d4a2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLAdvanz Pharma (US) Corp.19ef66d1-913f-49a8-a0a5-59b4e20322f52025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8b82ad14-580c-4145-b825-dce849f953632025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
rxcui: 1359028
unii: 423D2T571U
unii: 9S44LIC7OJ
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: C151H8M554
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLPrasco Laboratoriesf0d80e01-f4f5-4b1a-bc9e-50a2bd4390b12025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Loestrin Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATETeva Women's Health LLCf29ebcb5-7e65-4092-bfaa-f5ec026fc2552025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
rxcui: 1359028
unii: 423D2T571U
unii: 9S44LIC7OJ
LUIZZA 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed LLCb1c3e33d-ec95-cd89-7ad9-36994c802a1f2025-02-12Warnings, Adverse reactionsExact identifier
rxcui: 1359022
rxcui: 1359028
unii: 423D2T571U
unii: 9S44LIC7OJ
Anise PyriteANISE PYRITEUriel Pharmacy Inc.a03cdeb0-8347-40cc-8d17-5510d99575c72025-01-22WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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