NDC 50419-451-01 - Climara
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
- 50419-451
- Requested NDC
- 50419-451-01
- Package NDCs from labels
- 50419-451-01, 50419-451-04
- Manufacturer
- Bayer HealthCare Pharmaceuticals Inc. | Kindeva Drug Delivery L.P. | Sixarp, LLC
- Effective date
- 2026-03-26
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Climara - Bayer HealthCare Pharmaceuticals Inc. | Kindeva Drug Delivery L.P. | Sixarp, LLC | Bayer HealthCare Pharmaceuticals Inc. | Kindeva Drug Delivery L.P. | Sixarp, LLC | 2026-03-26 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50419-451-01 | Climara | 7 d in 1 PATCH | PATCH | 7 | 25 | |
| 50419-451-04 | Climara | 4 in 1 CARTON | PATCH | 4 | 25 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50419-451-01 | EA - Each | 50419-451 | 86a8fe65-1afc-48ac-be70-8093d9e46ac1 | 1 | 2015-08-04 |
| 50419-451-04 | EA - Each | 50419-451 | 5ea8eafa-59f2-47d4-94dd-f742080769e3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | CLIMARA (ESTRADIOL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | CLIMARA (ESTRADIOL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 |
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 |
|---|---|---|---|---|---|---|
| Estradiol | ESTRADIOL | Amneal Pharmaceuticals of New York LLC | 094830ee-1b1c-4cf7-8a39-427dfd56f9c9 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | Teva Pharmaceuticals USA, Inc. | 8cb31c7c-fba8-4201-833d-844ea1a8a4de | 2024-04-01 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Dr Dale Wellness NU Fem 1 2 3 All In One Topical Homeopathic | DHEA,ADRENAL CORTISOL,GLANDULA SUPRARENALIS SUIS,HUMAN GROWTH HORMONE,IGF-I,IGF-II ,HYPOTHALAMUS,PITUITARY,PLACENTA,LIVER,THYMUS,RNA,DNA,ESTROGENIUM,ESTRADIOLINUM,SANGUINARA CANDENSIS,OOPHORINUM,PROGESTERONIUM,PITITUARINUM,PINEAL,FOLLICULINUM,OVARINUM,CHELADONIUM,SULPHUR,SEPIA,LAGENINE ,TESTOSTERONE,CIMICIFUGA BLACK COHOSH,LILIUM TIGRINUM,GRAPHITES,KALI PHOSPHORICUM ,CAUSTICUM,CALCAREA CARBONICA,PHYTOLACCA,SCROPHULARIA NODOSA | DMD Clinical Naturopathy | 7679472c-bc6a-40c1-8e66-adc0b6ca18b4 | 2024-03-21 | Warnings | 4TI98Z838E |
| estradiol | ESTRADIOL | Zydus Pharmaceuticals USA Inc. | 684850eb-d889-4370-a0a7-4a5c3113266a | 2024-03-20 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| estradiol | ESTRADIOL | Zydus Pharmaceuticals USA Inc. | db4696da-7820-4b2b-97b4-fb05b1208020 | 2024-03-20 | Boxed warning, Warnings, Adverse reactions | 238003 238004 242333 403923 403922 241527 4TI98Z838E |
| Estradiol | ESTRADIOL | Zydus Pharmaceuticals USA Inc. | 839fe7ae-6835-4d6a-b6b1-ca7f062caa4f | 2024-03-15 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| High Vitality | AGNUS CASTUS, AMBRA GRISEA, PETROSELINUM SATIVUM, ESTRADIOL, L-DOPA, MELATONIN, TESTOSTERONE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, FUNICULUS UMBILICALIS SUIS, GABA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), APIOLUM, | Deseret Biologicals, Inc. | 2fd79cc1-42ed-49f5-b9e1-c48dedd21b1c | 2024-03-13 | Warnings | 4TI98Z838E |
| Etyqa | ESTRADIOL AND NORETHINDRONE ACETATE | Aurobindo Pharma Limited | afbc2a33-5eb2-4f01-91e9-07d8050da6ce | 2024-03-01 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| CombiPatch (estradiol/norethindrone acetate transdermal system) | ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM | Noven Therapeutics, LLC | 83198ef1-11c4-11e4-9191-0800200c9a66 | 2024-02-21 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol / Norethindrone Acetate | ESTRADIOL AND NORETHINDRONE ACETATE | Breckenridge Pharmaceutical, Inc. | 44125b2f-10ac-435c-bdb4-a29bf8450dbf | 2024-02-21 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | Teva Pharmaceuticals USA, Inc. | c4936878-1643-4e7f-9b0d-e4957935aef2 | 2024-02-01 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| ELESTRIN | ESTRADIOL | Viatris Specialty LLC | eff2dea1-f117-11e3-ac10-0800200c9a66 | 2023-12-15 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| High Vitality Tab | AGNUS CASTUS, AMBRA GRISEA, ESTRADIOL, L-DOPA, MELATONIN, PETROSELINUM SATIVUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, TESTOSTERONE, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), HUMAN GROWTH HORMONE, | Deseret Biologicals | 4040e55f-9d59-483e-bba1-ec6cd6869375 | 2023-12-12 | Warnings | 4TI98Z838E |
| Activella | ESTRADIOL/NORETHINDRONE ACETATE | Amneal Pharmaceuticals LLC | d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0 | 2023-11-30 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Vivelle-Dot | ESTRADIOL | Sandoz Inc | 5ccb77f9-d47b-4381-ad5c-5b92524e1c4a | 2023-11-17 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Lipotox | SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, | BioActive Nutritional, Inc. | a1538692-ca00-4e52-9b7e-409767ee27e1 | 2023-09-05 | Warnings | 4TI98Z838E |
| Estrogen 4X | ESTRADIOL | Nutritional Specialties, Inc. | 772c2a8a-10e2-49af-8db6-4d5ca64b1719 | 2023-07-25 | Warnings | 4TI98Z838E |
| estradiol | ESTRADIOL | Zydus Lifesciences Limited | 2f2030c2-f72e-4142-9cff-540bc8fbf8a1 | 2023-04-21 | 4TI98Z838E | |
| estradiol | ESTRADIOL | Zydus Lifesciences Limited | 8b672c79-0896-4d6e-b225-299e89068ad7 | 2023-04-21 | 238003 238004 242333 403923 403922 241527 4TI98Z838E | |
| Young Again | AGNUS CASTUS, AMBRA GRISEA, PETROSELINUM SATIVUM, ESTRADIOL, L-DOPA, MELATONIN, TESTOSTERONE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), HUMAN GROWTH HORMONE, | Dr. Donna Restivo DC | b29089e4-83e1-49ab-b5dd-2ef7fbb008e3 | 2023-01-10 | Warnings | 4TI98Z838E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.