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 |
|---|---|---|---|---|---|---|
| TARINA 24 FE | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | Afaxys Pharma, LLC | 557fa655-c40f-4ecb-bd18-4820c7e15e4b | 2023-11-01 | Boxed warning, Warnings, Adverse reactions | 1358762 |
| 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. | 0631d5e5-9da4-bcb7-e063-6394a90a62de | 2023-09-25 | Warnings | C151H8M554 |
| Vitalipid N | VITAMIN A PALMITATE, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE | Fresenius Kabi USA, LLC | 704119cc-d2ad-408a-b213-fe232f7fe2ba | 2023-09-07 | 7QWA1RIO01 | |
| 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. | 017f3bcf-0e45-d390-e063-6394a90a588e | 2023-07-28 | Warnings | C151H8M554 |
| 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. | 017f0210-195d-11d7-e063-6294a90aa750 | 2023-07-27 | Warnings | C151H8M554 |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | Amneal Pharmaceuticals NY LLC | d4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab | 2023-07-18 | Boxed warning, Warnings, Adverse reactions | 1358762 |
| Household Antigens | ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR | BioActive Nutritional | 3382df85-3ec5-4371-830e-4ed345b8f51b | 2023-07-14 | Warnings | 368GB5141J |
| Leaky Gut Formula | ALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, PANCREATINUM, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS) | Deseret Biologicals, Inc. | 8679e9ab-8610-47f1-be0e-66897f99881d | 2023-07-14 | Warnings | C151H8M554 |
| Pneumotox | TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM, | BioActive Nutritional, Inc. | f8846fb1-92e5-4f8e-b3b3-bc620df90a62 | 2023-07-12 | Warnings | 368GB5141J |
| Grain and Seed Antigens | AMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR | BioActive Nutritional, Inc. | 36ce44a5-e5ac-4eea-b76d-424dcd4e6b07 | 2023-06-20 | Warnings | C151H8M554 |
| Tri-Legest Fe 28 Day | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Teva Pharmaceuticals USA, Inc. | 6f9d30d9-5553-4cbd-a099-ff045bc85821 | 2023-03-21 | Boxed warning, Warnings, Adverse reactions | 1358762 |
| Saccharum officinale | SUCROSE | Boiron | 6858f374-8549-4b00-e053-2991aa0a5c3c | 2023-02-20 | C151H8M554 | |
| Saccharum Officinale | SACCHARUM OFFICINALE | Hahnemann Laboratories, INC. | f04b0ab3-af1c-ec2d-e053-2995a90a7855 | 2023-01-27 | C151H8M554 | |
| Petrochemical Detox | CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANS | Deseret Biologicals, Inc. | b38b492a-cf45-4aa2-ba7e-4573d2c4ebe5 | 2023-01-12 | Warnings | 368GB5141J |
| Chip Cravings | COUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUS | Dr. Donna Restivo DC | 719ef104-88f3-4db5-9c3a-1ac9a1a63c26 | 2023-01-10 | Warnings | C151H8M554 |
| Norethindrone Acetate | NORETHINDRONE ACETATE | Teva Pharmaceuticals USA, Inc. | f73f9807-4af6-4faa-ba9a-656a47a4c5e0 | 2022-11-30 | Warnings, Adverse reactions | 9S44LIC7OJ |
| Etonogestrel and Ethinyl Estradiol | ETONOGESTREL AND ETHINYL ESTRADIOL | Teva Pharmaceuticals USA, Inc. | a8cc104a-d522-49ad-af54-2f312b829b61 | 2022-09-30 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| ZAFEMY | NORELGESTROMIN AND ETHINYL ESTRADIOL | Amneal Pharmaceuticals LLC | 5ee34c07-65af-42b8-a98f-e299ff90a8a1 | 2022-04-30 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| Norelgestromin and Ethinly Estradiol | NORELGESTROMIN AND ETHINLY ESTRADIOL | Amneal Pharmaceuticals NY LLC | 36445b6a-e0f2-42f7-a8f3-5b80c90b87dd | 2022-03-30 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| XULANE | NORELGESTROMIN AND ETHINYL ESTRADIOL | Mylan Pharmaceuticals Inc. | f7848550-086a-43d8-8ae5-047f4b9e4382 | 2022-03-04 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.