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 2 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norvexa MiniNORVEXA MINIFlorrax Pharmaceutical7c964ffd-4b14-43ef-9163-db21c6a1afc62026-04-27Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDREMEDYREPACK INC.1b8ef3ea-5563-48ef-ba5e-27e0b454efb92026-04-23Boxed warningExact identifier
unii: R5L488RY0Q
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
ChromagenFERROUS ASPARTO GLYCINATE, FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, LEVOMEFOLATE GLUCOSAMINE, CYANOCOBALAMIN, ZINC, AND INTRINSIC FACTORAvion Pharmaceuticals, LLC13c5ed58-6333-498f-9ace-1049d7ae35522026-04-17Boxed warning, Adverse reactionsExact identifier
unii: R5L488RY0Q
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Pharmaceuticals USA Inc.10fa1458-c8ed-4197-922a-1ba7271d2b022026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Lifesciences Limited7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a92026-04-16Exact identifier
unii: 423D2T571U
PRENATE EnhanceASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLCcf10de09-6ed5-4a66-84fa-2da4f668bbe62026-04-14Boxed warning, Adverse reactionsExact identifier
unii: R5L488RY0Q
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERBryant Ranch Prepack790a9ec0-eb61-4148-86e9-91439e4dce892026-03-27WarningsExact identifier
unii: R5L488RY0Q
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLA-S Medication Solutions38924c83-53aa-4279-8f0e-1a5d8f5fd8ad2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERBryant Ranch Prepackf9f15374-4809-4b96-8a07-3c2f1011d1102026-03-18WarningsExact identifier
unii: R5L488RY0Q
Junel FEJUNEL FEDirect_Rxea62a66e-d45d-11be-e053-2a95a90a78012026-03-17Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: C151H8M554
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
PNV-DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CALCIUM, FERROUS FUMARATE, DOCONEXENTAcella Pharmaceuticals, LLC576e8bbb-1625-493c-85da-43caf2f02e3c2026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Floravita MiniFLORAVITA MINIFlorrax Pharmaceutical682bda57-21e0-47df-9596-78846d4d97c02026-02-12Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Hailey 24 FeNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATEGlenmark Pharmaceuticals Inc., USAab399c1c-5613-4e7d-88f7-ec41533d4da32026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA44fbc5ae-5682-471f-a12a-955e8b4d233a2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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