ESTRADIOL VAGINAL INSERTS is a Vaginal Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., Usa. The primary component is Estradiol.
| Product ID | 68462-711_15db09c3-5089-4ff1-a23f-ffdf884e95a2 |
| NDC | 68462-711 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ESTRADIOL VAGINAL INSERTS |
| Generic Name | Estradiol |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | VAGINAL |
| Marketing Start Date | 2018-09-17 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA210264 |
| Labeler Name | Glenmark Pharmaceuticals Inc., USA |
| Substance Name | ESTRADIOL |
| Active Ingredient Strength | 10 ug/1 |
| Pharm Classes | Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2018-09-17 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA210264 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-09-17 |
| Marketing Category | ANDA |
| Application Number | ANDA210264 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-09-17 |
| Ingredient | Strength |
|---|---|
| ESTRADIOL | 10 ug/1 |
| SPL SET ID: | 86620f6c-fd02-40df-98d5-3048dcd92c37 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68462-711 | ESTRADIOL VAGINAL INSERTS | ESTRADIOL VAGINAL INSERTS |
| 0023-5885 | Alora | Estradiol |
| 0023-5886 | Alora | Estradiol |
| 0023-5887 | Alora | Estradiol |
| 0023-5888 | Alora | Estradiol |
| 0037-4801 | ELESTRIN | ESTRADIOL |
| 0037-4802 | ELESTRIN | ESTRADIOL |
| 0013-2150 | Estring | estradiol |
| 0078-0343 | Vivelle-Dot | estradiol |
| 0078-0344 | Vivelle-Dot | estradiol |
| 0078-0345 | Vivelle-Dot | estradiol |
| 0078-0346 | Vivelle-Dot | estradiol |
| 0078-0365 | Vivelle-Dot | estradiol |