FDA.reportPublic FDA data

NDC 68462-503-84 - Hailey Fe 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
68462-503
Requested NDC
68462-503-84
Package NDCs from labels
68462-503-84, 68462-503-29
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 Fe 1.5/30 - Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2026-01-29HUMAN PRESCRIPTION DRUG LABEL
Hailey Fe 1.5/30 - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-09-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-503-29Hailey Fe 1.5/303 in 1 CARTONKIT311
68462-503-84Hailey Fe 1.5/301 in 1 POUCHKIT111
68462-503-84Hailey Fe 1.5/301 in 1 BLISTER PACKKIT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-503HAILEY FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [GLENMARK PHARMACEUTICALS INC., USA]10Current NDC, Legacy NDC, 3 package rows20230222_84f6d573-3022-4982-aaa4-ac69393210a2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-503-29EA - Each68462-50342a41ff6-20da-4fc7-af9c-8b4bd6f0aa9812020-07-13
68462-503-84EA - Each68462-503638ceeb4-8eed-42e1-9e3c-660d529d2dc112020-07-13

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 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Larin Fe 1/20NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATENorthstar Rx LLCe71741c8-10fa-4eee-b0da-e42af451222c2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
Larin 1.5/30NORETHINDRONE ACETATE/ETHINYL ESTRADIOLNorthstar Rx LLCe232ed29-e6f5-4591-8d61-68eb8b1596f02025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
Mibelas 24 FeNORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATELupin Pharmaceuticals, Inc.7281519c-069c-4ce3-a076-49848ad4ee7b2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
Larin 24 FeNORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATENorthstar Rx LLCea35800c-9a31-42b0-bb32-3404dce9e0e52025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
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
rxcui: 1359023
rxcui: 259176
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
rxcui: 1359023
rxcui: 259176
Blisovi 24 FeNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.1183b048-16f3-47a4-a42f-22ba07b2bb522025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
Blisovi Fe 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.ddbb5d60-cacf-4672-935d-86d6682879922025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLOrganon LLC55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d972025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERMETHOD PHARMACEUTICALS, LLC1f8785db-3e65-49d7-b017-b1a65b5ec6b12025-10-21WarningsExact identifier
unii: R5L488RY0Q
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
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
Tilia FeNDAC AND EE TABLETS AND FERROUS FUMARATE TABLETSMayne Pharma Inc.cebfb589-1b34-4f51-a0c8-c2c0cf4c71452025-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
MyfembreeRELUGOLIX, ESTRADIOL HEMIHYDRATE, AND NORETHINDRONE ACETATESumitomo Pharma America, Incfc3feb73-cc84-43a8-aa32-b262460495e82025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Microgestin Fe 1/20NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATEMayne Pharma Inc.5bf28e22-8f58-4166-8a62-2717ecd6a70f2025-08-04Warnings, Adverse reactionsExact identifier
rxcui: 259176
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
Junel Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEBryant Ranch Prepack13d7768b-ee41-46b0-93f4-5e8170dd338d2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176

Reported adverse events (FAERS/openFDA)#

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