Vagifem
- Product NDC
- 0169-5176
- 11-digit product format
- 001695176
- Labeler code
- 0169
- Product ID
- 0169-5176_9564f4b5-dbf2-429a-b058-f240e296cec9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol
- Dosage form
- INSERT
- Route
- VAGINAL
- Labeler
- Novo Nordisk
- Application
- NDA020908
- Marketing category
- NDA
- Marketing start
- 2010-01-11
- Substance
- ESTRADIOL
- Active strength
- 10 ug/1
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vagifem
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | 10 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E |
| Rxcui | 884707, 884709 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | VAGIFEM (ESTRADIOL) TABLET, FILM COATED [NOVO NORDISK] | 10 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | VAGIFEM (ESTRADIOL) TABLET, FILM COATED [NOVO NORDISK] | 10 | |
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | VAGIFEM (ESTRADIOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | VAGIFEM (ESTRADIOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | VAGIFEM (ESTRADIOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0169-5176 | VAGIFEM (ESTRADIOL) INSERT [NOVO NORDISK] | 22 | Current NDC, Legacy NDC, 6 package rows | 20250212_e5ad3cf6-dd96-4e64-af21-c1eee38d0b88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0169-5176-03 | 00169517603 | 8 APPLICATOR in 1 CARTON (0169-5176-03) / 1 INSERT in 1 APPLICATOR | 8 applicator | 2010-01-11 | 0000-00-00 | No | No | Current |
| 0169-5176-04 | 00169517604 | 18 APPLICATOR in 1 CARTON (0169-5176-04) / 1 INSERT in 1 APPLICATOR | 18 applicator | 2010-01-11 | 0000-00-00 | No | No | Current |
| 0169-5176-99 | 00169517699 | 6 APPLICATOR in 1 CARTON (0169-5176-99) / 1 INSERT in 1 APPLICATOR | 6 applicator | 2010-01-11 | 0000-00-00 | No | No | Current |