NDC 0378-7280-85 - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
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
- 0378-7280
- Requested NDC
- 0378-7280-85
- Package NDCs from labels
- 0378-7280-85, 0378-7280-53
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Effective date
- 2024-01-15
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg | Mylan Pharmaceuticals Inc. | 2024-01-15 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-7280-53 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 3 in 1 CARTON | TABLET | 3 | 10 | |
| 0378-7280-85 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 21 in 1 BLISTER PACK | TABLET | 21 | 10 | |
| 0378-7280-85 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 1 in 1 POUCH | TABLET | 1 | 10 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-7280-53 | EA - Each | 0378-7280 | c809bc41-de91-498e-9904-a5df9dcd0333 | 1 | 2014-08-01 |
| 0378-7280-85 | EA - Each | 0378-7280 | 00920816-31d5-4249-b91d-978f1e5f8182 | 1 | 2018-08-13 |
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 |
|---|---|---|---|---|---|---|
| Etonogestrel and Ethinyl Estradiol Vaginal Ring | ETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RING | Northstar Rx LLC | 1488f5ae-3b34-fcd7-6049-215929b1d324 | 2024-06-24 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| EnilloRing | ETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL | Xiromed, LLC | 85a126f6-d3e0-9e12-73f9-6176ba36f58b | 2024-06-24 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL AND NORETHINDRONE ACETATE | Naari Pte. Limited | f70185fe-9fcf-655f-e053-6394a90a20dc | 2024-06-11 | Boxed warning, Warnings, Adverse reactions | 9S44LIC7OJ |
| Microgestin 1/20 | NORETHINDRONE ACETATE/ETHINYL ESTRADIOL | Dr.Reddy's Laboratories Inc. | 8754135b-5a8e-4cc1-a66c-c2f6a3c90005 | 2024-06-01 | Boxed warning, Warnings, Adverse reactions | 1358776 1358762 |
| Tilia Fe | NDAC AND EE TABLETS AND FERROUS FUMARATE TABLETS | Dr. Reddys Laboratories Inc. | 118fb017-b44d-4223-ac5a-501ca96de210 | 2024-06-01 | Boxed warning, Warnings, Adverse reactions | 1358762 |
| Mimvey | ESTRADIOL AND NORETHINDRONE ACETATE | Teva Pharmaceuticals USA, Inc. | b1c5c06b-9ce2-4bf7-9693-e37608055a14 | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 9S44LIC7OJ |
| Allergies | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM | Newton Laboratories, Inc. | 9d5dea47-5103-21a3-e053-2995a90aee78 | 2024-05-20 | Warnings | C151H8M554 |
| Intimate | NATRUM CARBONICUM, SACCHARUM OFFICINALE, LITHIUM CARBONICUM, PLACENTA TOTALIS SUIS, LAC CANINUM, ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, GERMANIUM METALLICUM, HELLEBORUS NIGER, MAGNESIA OXYDATA, RHUS GLABRA, STRAMONIUM, THUJA OCCIDENTALIS, DNA (HUMAN), OXYTOCIN, HYDROGEN, NEON, LAC MATERNA HUMANUM | Deseret Biologicals, Inc. | ca0447c1-606e-443a-b789-7d65143fec28 | 2024-05-13 | Warnings | C151H8M554 |
| Enviroclenz | BERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM | Deseret Biologicals, Inc. | 92816bbe-96d6-45fc-9929-d3e6df394a33 | 2024-05-02 | Warnings | 368GB5141J |
| Microgestin Fe 1/20 | NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE | Dr. Reddy's Laboratories Inc. | 5e622180-cbb0-4466-a810-98b3b9663b59 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | 1358762 |
| Glyreg | ACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCA | Deseret Biologicals, Inc | 28e670ca-ed35-4256-af20-74c25dc18099 | 2024-04-23 | Warnings | C151H8M554 |
| Envirotox | TRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM. | BioActive Nutritional, Inc. | 2b5cfdba-cf4d-4eb0-8c60-20eac6922663 | 2024-03-26 | Warnings | 368GB5141J |
| Habit | CHAMOMILLA, NATRUM PHOSPHORICUM, VALERIANA OFFICINALIS, PASSIFLORA INCARNATA, ARGENTUM NITRICUM, CALADIUM SEGUINUM, CINCHONA OFFICINALIS, MURIATICUM ACIDUM, SACCHARUM OFFICINALE, AVENA SATIVA, TABACUM, CEREBRUM SUIS, SEROTONIN (HYDROCHLORIDE), ARGEMONE MEXICANA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, AURUM METALLICUM, IPECACUANHA, SEPIA, HYPOTHALAMUS (BOVINE), VIPERA BERUS | Deseret Biologicals, Inc. | 3d00a305-e15d-4419-97bd-332421d4a1b0 | 2024-03-15 | Warnings | C151H8M554 |
| Leaky Gut Formula | ALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS) | Deseret Biologicals, Inc. | 7e3a254b-a43d-43a2-a777-0d0c0057e131 | 2024-03-14 | Warnings | C151H8M554 |
| NUVARING | ETONOGESTREL AND ETHINYL ESTRADIOL | A-S Medication Solutions | e14bc197-dd22-4e6e-8aa1-d6cf2242fe0f | 2024-03-10 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| Allergies | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM | Newton Laboratories, Inc. | 9d4c4d88-43da-49dd-e053-2995a90af18d | 2024-03-07 | Warnings | C151H8M554 |
| Cand Plus | HYDRASTIS CANADENSIS, BERBERIS VULGARIS, BORAX, SACCHARUM OFFICINALE, CAFFEINUM, GALLICUM ACIDUM, INDOLUM, ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), ASAFOETIDA, ACETALDEHYDE, FOLLICULINUM, LYCOPODIUM CLAVATUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), SEPIA, USTILAGO MAIDIS, TORULA CEREVISIAE | Deseret Biologicals, Inc. | 1f8ab864-27c2-4457-8ad7-5d65f9983e2c | 2024-03-06 | Warnings | C151H8M554 |
| Etyqa | ESTRADIOL AND NORETHINDRONE ACETATE | Aurobindo Pharma Limited | afbc2a33-5eb2-4f01-91e9-07d8050da6ce | 2024-03-01 | Boxed warning, Warnings, Adverse reactions | 9S44LIC7OJ |
| Jinteli | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Teva Pharmaceuticals USA, Inc. | d667ca75-1a17-43fc-9077-f25ce0908f8d | 2024-02-27 | Boxed warning, Warnings, Adverse reactions | 423D2T571U 9S44LIC7OJ |
| XULANE | NORELGESTROMIN AND ETHINYL ESTRADIOL | A-S Medication Solutions | adcf17ef-e60b-48a4-9478-3998dab2bbbd | 2024-02-27 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.