NDC 68968-0525-08 - CombiPatch (estradiol/norethindrone acetate transdermal system)
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
- 68968-0525
- Requested NDC
- 68968-0525-08
- Package NDCs from labels
- 68968-0525-8, 68968-0525-08
- Manufacturer
- Noven Therapeutics, LLC | Noven Pharmaceuticals, Inc.
- Effective date
- 2024-02-21
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| DIPROPYLENE GLYCOL - Noven Therapeutics, LLC | Noven Pharmaceuticals, Inc. | Noven Therapeutics, LLC | Noven Pharmaceuticals, Inc. | 2024-02-21 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68968-0525-8 | CombiPatch (estradiol/norethindrone acetate transdermal system) | 1 in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | 14 | |
| 68968-0525-8 | CombiPatch (estradiol/norethindrone acetate transdermal system) | 8 in 1 CARTON | PATCH, EXTENDED RELEASE | 8 | 14 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68968-0525 | COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20240224_83198ef1-11c4-11e4-9191-0800200c9a66.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68968-0525-1 | EA - Each | 68968-0525 | 426bc78e-9aff-4623-9ee7-ca5a00bc2452 | 1 | 2015-11-12 |
| 68968-0525-8 | EA - Each | 68968-0525 | 904abe69-ba94-4836-ba9b-23c52a280489 | 1 | 2014-10-03 |
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 |
|---|---|---|---|---|---|---|
| Estriora Cream | ESTRIOL AND ESTRADIOL CREAM | Guangzhou Shunfei Network Technology Co., Ltd. | 5a53c026-aa7c-6c09-e063-6394a90a36e1 | 2026-08-31 | Warnings | 4TI98Z838E |
| Estradiol | ESTRADIOL | A-S Medication Solutions | c8a2d29c-299c-4559-b859-87b303a4af81 | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Gynobalance | DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE | BioActive Nutritional, Inc. | 61fa6e6e-42f5-4992-87b5-0770218abc8c | 2026-08-24 | Warnings | 4TI98Z838E |
| Estradiol | ESTRADIOL | Trigen Laboratories, LLC | e84ad638-6768-41aa-b2b8-e2514ef63881 | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Minivelle | ESTRADIOL | Noven Therapeutics, LLC | 6c5c47ab-28ee-11e1-bfc2-0800200c9a66 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | Redpharm Drug | 5718f042-e8c0-b721-e063-6294a90a5bef | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| ESTRADIOL | ESTRADIOL | A-S Medication Solutions | 5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol / Norethindrone Acetate | ESTRADIOL AND NORETHINDRONE ACETATE | A-S Medication Solutions | e166bdf6-eb60-49b8-9747-2a33c3e3461b | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E 9S44LIC7OJ |
| Estradiol and Norethindrone Acetate | ESTRADIOL AND NORETHINDRONE ACETATE | A-S Medication Solutions | 1521007a-546d-421e-99e1-e10d90c0b090 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E 9S44LIC7OJ |
| Estradiol | ESTRADIOL | ANI Pharmaceuticals, Inc. | ff28c624-906d-459c-8b8c-27cb1a664e12 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol Vaginal | ESTRADIOL | Redpharm Drug | 546c168d-2a85-69b6-e063-6294a90a22ac | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | e6bf2abc-71ae-4e79-a37b-164c98ba746a | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 34bcec8e-c7a6-4a1c-9884-4d4efe024bb9 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | REMEDYREPACK INC. | 41f7a56c-4ce3-4cc6-803e-1ff662efef90 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | REMEDYREPACK INC. | 59a4b68d-a507-4809-a0c8-fd9799986d12 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | A-S Medication Solutions | ba935918-39b3-4b56-bd83-78a29958e6d8 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 1c38f0d0-a360-4b66-bc0e-7d54e92465a1 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| ESTRADIOL | ESTRADIOL | REMEDYREPACK INC. | 477cb52e-8ce2-491f-94a0-869ff60bf7ab | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | A-S Medication Solutions | eacafc4a-2fa8-403d-8df7-2bc92d73a54f | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | A-S Medication Solutions | ee5460ab-27e7-487a-a89c-bf8735399be6 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.