NDC 0378-4641-16 - 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
- 0378-4641
- Requested NDC
- 0378-4641-16
- Package NDCs from labels
- 0378-4641-16, 0378-4641-26
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Effective date
- 2025-06-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Estradiol - Mylan Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. | 2025-06-17 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-4641-16 | Estradiol | 3.5 d in 1 PATCH | PATCH | 3.5 | 14 | |
| 0378-4641-16 | Estradiol | 1 in 1 POUCH | PATCH | 1 | 14 | |
| 0378-4641-26 | Estradiol | 8 in 1 CARTON | PATCH | 8 | 14 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-4641-16 | EA - Each | 0378-4641 | c16c873b-37ad-4ce8-b16a-869e2ff3b8a3 | 1 | 2018-05-09 |
| 0378-4641-26 | EA - Each | 0378-4641 | aa9e71af-dae5-41f5-904f-6cbe7bd5db60 | 1 | 2015-01-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.] | 4 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.] | 4 | |
| DIPROPYLENE GLYCOL | INACTIVE INGREDIENT | E107L85C40 | ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.] | 4 | |
| OLEYL ALCOHOL | INACTIVE INGREDIENT | 172F2WN8DV | ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.] | 4 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.] | 4 |
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 Vaginal | ESTRADIOL | Bryant Ranch Prepack | e7b15ec3-e195-44a6-bdd7-9b6de2b235b8 | 2024-07-26 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 7f3c96ce-c855-4372-95ba-7759dd82bcca | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| ESTRADIOL | ESTRADIOL | NuCare Pharmaceuticals, Inc. | 5423c0da-eb10-20cd-e054-00144ff8d46c | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| DOTTI | ESTRADIOL | Bryant Ranch Prepack | 99b889a0-6200-4727-97d3-f5a0b7814e1b | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 248478 4TI98Z838E |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 9eb88585-4994-474f-bd63-c4e003bf6f20 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 7eb1b2c3-8ece-47c3-96c0-606f7f5b5a32 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | d9514497-6b9e-4c13-950b-6b036ff101c1 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | NuCare Pharmaceuticals,Inc. | 1bbdb10b-9a32-3899-e063-6294a90ab26d | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | NuCare Pharmaceuticals,Inc. | 9c1c4911-908e-3c3c-e053-2995a90abcfc | 2024-06-14 | Warnings | FZ989GH94E |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL AND NORETHINDRONE ACETATE | Naari Pte. Limited | f70185fe-9fcf-655f-e053-6394a90a20dc | 2024-06-11 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| ESTRADIOL | ESTRADIOL | NuCare Pharmaceuticals,Inc. | 7093dbe4-b096-2ddb-e053-2991aa0a1bb8 | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Mimvey | ESTRADIOL AND NORETHINDRONE ACETATE | Teva Pharmaceuticals USA, Inc. | b1c5c06b-9ce2-4bf7-9693-e37608055a14 | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| ESTRACE | ESTRADIOL | Allergan, Inc. | dfc41fcd-c5ba-4b25-b647-cf04d3988b3e | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | Amneal Pharmaceuticals NY LLC | d4259bb8-91f8-4587-8ceb-35d44145aec0 | 2024-05-15 | Boxed warning, Warnings, Adverse reactions | 1149632 242892 242891 248478 241946 4TI98Z838E |
| LYLLANA | ESTRADIOL | Amneal Pharmaceuticals LLC | 09c472c6-a38a-4a3d-b048-6fefd52e2ad3 | 2024-05-15 | Boxed warning, Warnings, Adverse reactions | 1149632 242892 242891 248478 241946 4TI98Z838E |
| Estradiol | ESTRADIOL | Amneal Pharmaceuticals NY LLC | 0500ee9b-bf4a-4432-9afe-20a7d60a6fe5 | 2024-05-14 | Boxed warning, Warnings, Adverse reactions | 1149632 242892 242891 248478 241946 4TI98Z838E |
| DOTTI | ESTRADIOL | Amneal Pharmaceuticals LLC | 53016d30-6b5f-49da-ac16-85ef415a5805 | 2024-05-14 | Boxed warning, Warnings, Adverse reactions | 1149632 242892 242891 248478 241946 4TI98Z838E |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | 0e927450-3f02-4d2f-9235-a255357e8d93 | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | 6a4e82a4-d980-4c04-9e33-9444a292728a | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | eab9a629-b3d4-4faf-bce4-656fe3b46d38 | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.