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 2 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hailey 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA021df70a-0c37-4237-a2f7-2597ff6d41f52026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209297
ndc (package): 68462-504-81
ndc (package): 68462-504-79
ndc (product): 68462-504
ndc11 (package): 68462050479
rxcui: 1359022
rxcui: 2047760
rxcui: 1359028
spl id: 299fb286-ee60-4950-8315-d310c6ce29cd
spl set id: 021df70a-0c37-4237-a2f7-2597ff6d41f5
unii: 423D2T571U
unii: 9S44LIC7OJ
Norethindrone AcetateNORETHINDRONE ACETATEGlenmark Pharmaceuticals Inc., USAd0a94321-eb60-4aa6-a429-f0156f9f8e012026-01-29Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
Hailey Fe 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEGlenmark Pharmaceuticals Inc., USA84f6d573-3022-4982-aaa4-ac69393210a22026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAvKAREfbbd12dd-c538-2869-e053-6294a90a1a382026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Norethindrone AcetateNORETHINDRONE ACETATEAmerican Health Packagingeb0b80e0-5b69-4efa-ae8a-62e718a62dc32026-01-14Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Southeast Regional 1024SOUTHEAST REGIONALProfessional Complementary Health Formulas7a4ff3cf-6897-4cca-b907-556270642e042026-01-08WarningsExact identifier
unii: 5C5403N26O
Trees 2 1017TREES 2Professional Complementary Health Formulas601c8ffe-35c2-4dcc-a503-7d9b9998e2842026-01-08WarningsExact identifier
unii: 5C5403N26O
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: C151H8M554
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: C151H8M554
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
FyavolvNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.772c86d7-10a4-48c5-8c19-f8aac68f5ab42026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Larin 1.5/30NORETHINDRONE ACETATE/ETHINYL ESTRADIOLNorthstar Rx LLCe232ed29-e6f5-4591-8d61-68eb8b1596f02025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
rxcui: 1359028
Larin Fe 1.5/30NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATENorthstar Rx LLCee79a7fa-1c64-4b7b-822c-e0ddefc8ef862025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
BLISOVI FE 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.5c5f2307-8679-4e34-9bcd-c22219b14a152025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLOrganon LLC55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d972025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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