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 7 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: C151H8M554
Saccharum officinaleSUCROSEBoiron6858f374-8549-4b00-e053-2991aa0a5c3c2023-02-20Exact identifier
unii: C151H8M554
Saccharum OfficinaleSACCHARUM OFFICINALEHahnemann Laboratories, INC.f04b0ab3-af1c-ec2d-e053-2995a90a78552023-01-27Exact identifier
unii: C151H8M554
Chip CravingsCOUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUSDr. Donna Restivo DC719ef104-88f3-4db5-9c3a-1ac9a1a63c262023-01-10WarningsExact identifier
unii: C151H8M554
Junel Fe 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATEProficient Rx LP253c6b2e-2c93-4ee7-94a6-fd063c569c1f2022-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
Norethindrone AcetateNORETHINDRONE ACETATETeva Pharmaceuticals USA, Inc.f73f9807-4af6-4faa-ba9a-656a47a4c5e02022-11-30Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Etonogestrel and Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a8cc104a-d522-49ad-af54-2f312b829b612022-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLC5ee34c07-65af-42b8-a98f-e299ff90a8a12022-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norelgestromin and Ethinly EstradiolNORELGESTROMIN AND ETHINLY ESTRADIOLAmneal Pharmaceuticals NY LLC36445b6a-e0f2-42f7-a8f3-5b80c90b87dd2022-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
XULANENORELGESTROMIN AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.f7848550-086a-43d8-8ae5-047f4b9e43822022-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
AmethystLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals, Inc.99073fe0-eac8-44dd-abe6-623fa67d9e792022-01-31Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
TH-101CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROBTemple Health Nutrition, LLCd54bb860-560c-4f8f-9aea-a0b7774cc92b2021-12-29WarningsExact identifier
unii: C151H8M554
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.140c50d6-c931-423a-9aa0-526eae7ab93c2021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9a61f1ae-d3a4-68d7-e053-2a95a90a43332020-12-03WarningsExact identifier
unii: C151H8M554
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9aefc830-329c-5e35-e053-2a95a90a6ffe2020-11-30WarningsExact identifier
unii: C151H8M554
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9af2d6f4-baa8-5da9-e053-2995a90a3dac2020-11-30WarningsExact identifier
unii: C151H8M554
Microgestin Fe 1.5/30NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATEMayne Pharma Inc.1587721b-0d71-4fe7-9e34-eac41a1152032020-10-23Warnings, Adverse reactionsExact identifier
rxcui: 1359022
LopreezaESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals NY LLCbf0e39cb-95e7-4831-92d2-0b3f071aeaae2017-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ

Reported adverse events (FAERS/openFDA)#

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