NDC 0378-7301-85 - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
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
- 0378-7301
- Requested NDC
- 0378-7301-85
- Package NDCs from labels
- 0378-7301-85, 0378-7301-53
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Effective date
- 2018-02-07
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL - Mylan Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. | 2018-02-07 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-7301-53 | EA - Each | 0378-7301 | 4009bb51-ed3d-404c-80b8-77db01ff223e | 1 | 2014-11-05 |
| 0378-7301-85 | EA - Each | 0378-7301 | a95332d2-066f-425f-8339-f2623a6a2a03 | 1 | 2018-11-06 |
DailyMed Socrata Ingredients#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pollen Hayfever | ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUM | NaturalCare | 00665933-176e-4f16-b6ee-b55217b8abb3 | 2026-05-05 | Warnings | ETJ7Z6XBU4 |
| Hydrate I | COFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEA | BioActive Nutritional, Inc. | c0c8d350-0257-4484-acd8-f852350173db | 2026-04-30 | Warnings | ETJ7Z6XBU4 |
| Norvexa Mini | NORVEXA MINI | Florrax Pharmaceutical | 7c964ffd-4b14-43ef-9163-db21c6a1afc6 | 2026-04-27 | Warnings, Adverse reactions | R5L488RY0Q |
| Prenatal Plus Vitamins | PRENATAL WITH FERROUS FUMARATE AND FOLIC ACID | REMEDYREPACK INC. | 1b8ef3ea-5563-48ef-ba5e-27e0b454efb9 | 2026-04-23 | Boxed warning | R5L488RY0Q |
| Chromagen | FERROUS ASPARTO GLYCINATE, FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, LEVOMEFOLATE GLUCOSAMINE, CYANOCOBALAMIN, ZINC, AND INTRINSIC FACTOR | Avion Pharmaceuticals, LLC | 13c5ed58-6333-498f-9ace-1049d7ae3552 | 2026-04-17 | Boxed warning, Adverse reactions | R5L488RY0Q |
| PRENATE DHA | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, FOLIC ACID, LEVOMEFOLATE CALCIUM, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, MAGNESIUM OXIDE AND DOCONEXENT | Avion Pharmaceuticals, LLC | 8f2eca71-9a82-4a19-9206-36a04b865fe1 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | 7QWA1RIO01 |
| norelgestromin and ethinyl estradiol | NORELGESTROMIN AND ETHINYL ESTRADIOL | Zydus Pharmaceuticals USA Inc. | 10fa1458-c8ed-4197-922a-1ba7271d2b02 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| norelgestromin and ethinyl estradiol | NORELGESTROMIN AND ETHINYL ESTRADIOL | Zydus Lifesciences Limited | 7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a9 | 2026-04-16 | 423D2T571U | |
| PRENATE Enhance | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENT | Avion Pharmaceuticals, LLC | cf10de09-6ed5-4a66-84fa-2da4f668bbe6 | 2026-04-14 | Boxed warning, Adverse reactions | R5L488RY0Q |
| Dentastat | ALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PALLADIUM METALLICUM, PHOSPHORUS, SILICEA, TITANIUM METALLICUM, ZINCUM METALLICUM, PLATINUM METALLICUM, PYROGENIUM | Energique, Inc. | 7f6d360b-9fee-4374-a47c-847806d54fa0 | 2026-04-13 | Warnings | ETJ7Z6XBU4 |
| Animal Hair and Dander | ADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, CAT (DANDER), DOG (DANDER), EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, SABADILLA, SHEEP WOOL, SILICEA | NaturalCare | f0067255-9310-43a0-b415-c03a0f554bcc | 2026-04-10 | Warnings | ETJ7Z6XBU4 |
| Quantum Resonance | ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM | Deseret Biologicals, Inc. | f94a10bd-1c40-42c7-b458-b58070614549 | 2026-04-10 | Warnings | ETJ7Z6XBU4 |
| Quantum Resonance | ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM | Deseret Biologicals, Inc. | 1467111a-bef6-473d-b7f2-3309a9bb72ce | 2026-04-10 | Warnings | ETJ7Z6XBU4 |
| Connection | ANACARDIUM 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 OCCIDENTALIS | Deseret Biologicals, Inc. | 4a8be3aa-9bd9-4bb1-af98-a940c13b2bd0 | 2026-04-10 | Warnings | C151H8M554 |
| Connection | ANACARDIUM 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 OCCIDENTALIS | Deseret Biologicals, Inc. | 214eb19a-e7a2-421c-9f34-724ce430185c | 2026-04-10 | Warnings | C151H8M554 |
| H-Focus Formula | AGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUM | Healing Natural Oils LLC | 4ee42911-3064-7f55-e063-6294a90abcc7 | 2026-04-07 | Warnings | ETJ7Z6XBU4 |
| H-Mood Formula | AGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUM | Healing Natural Oils LLC | 4ee5c82e-9edf-c36e-e063-6394a90a237f | 2026-04-07 | Warnings | ETJ7Z6XBU4 |
| Sinus Defense | LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE | Micro Balance Health Products LLC | 9c2f51c5-aa41-414e-a966-32e02e9e79a2 | 2026-04-02 | Warnings | ETJ7Z6XBU4 |
| Acne HP | CARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUM | BioActive Nutritional, Inc. | 2ab4ff53-4274-40c7-b05c-44d918d809be | 2026-03-31 | Warnings | ETJ7Z6XBU4 |
| Lymphoplex | MYRRHA, TRIGONELLA FOENUM-GRAECUM, PINUS SYLVESTRIS, LYMPH (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRANGEA ARBORESCENS, PHYTOLACCA DECANDRA, SILICEA | BioActive Nutritional, Inc. | 624f35db-291e-4e7f-a2c9-ae319717157a | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.