NDC 0169-5176
Vagifem
Estradiol
Vagifem is a Vaginal Insert in the Human Prescription Drug category. It is labeled and distributed by Novo Nordisk. The primary component is Estradiol.
| Product ID | 0169-5176_231819ab-9066-4b6b-8921-da4eaa7696af |
| NDC | 0169-5176 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Vagifem |
| Generic Name | Estradiol |
| Dosage Form | Insert |
| Route of Administration | VAGINAL |
| Marketing Start Date | 2010-01-11 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020908 |
| Labeler Name | Novo Nordisk |
| 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 |
Packaging
NDC 0169-5176-03
8 APPLICATOR in 1 CARTON (0169-5176-03) > 1 INSERT in 1 APPLICATOR
| Marketing Start Date | 2010-01-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0169-5176-99 [00169517699]
Vagifem INSERT
| Marketing Category | NDA |
| Application Number | NDA020908 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-01-11 |
NDC 0169-5176-03 [00169517603]
Vagifem INSERT
| Marketing Category | NDA |
| Application Number | NDA020908 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-11 |
NDC 0169-5176-04 [00169517604]
Vagifem INSERT
| Marketing Category | NDA |
| Application Number | NDA020908 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-11 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ESTRADIOL | 10 ug/1 |
OpenFDA Data
| SPL SET ID: | e5ad3cf6-dd96-4e64-af21-c1eee38d0b88 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Estradiol Congeners [CS]
- Estrogen [EPC]
- Estrogen Receptor Agonists [MoA]
NDC Crossover Matching brand name "Vagifem" or generic name "Estradiol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0169-5176 | Vagifem | Vagifem |
| 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 |
Trademark Results [Vagifem]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VAGIFEM 75222116 2123814 Live/Registered |
NOVO NORDISK HEALTH CARE AG 1997-01-07 |
 VAGIFEM 75216258 2125531 Dead/Cancelled |
Novo Nordisk A/S 1996-12-20 |
 VAGIFEM 73805479 1601821 Dead/Cancelled |
NOVO INDUSTRI A/S 1989-06-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.