ESTRADIOL VAGINAL INSERTS
- Product NDC
- 68462-711
- 11-digit product format
- 684620711
- Labeler code
- 68462
- Product ID
- 68462-711_732fcf7c-ebfa-4c6d-a06e-5e2ed8d90ef7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol
- Dosage form
- TABLET, FILM COATED
- Route
- VAGINAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA210264
- Marketing category
- ANDA
- Marketing start
- 2018-09-17
- 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
- ESTRADIOL VAGINAL INSERTS
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-711-71 | ESTRADIOL VAGINAL INSERTS | 8 in 1 CARTON | TABLET, FILM COATED | 8 | | 7 |
| 68462-711-71 | ESTRADIOL VAGINAL INSERTS | 1 in 1 APPLICATOR | TABLET, FILM COATED | 1 | | 7 |
| 68462-711-88 | ESTRADIOL VAGINAL INSERTS | 18 in 1 CARTON | TABLET, FILM COATED | 18 | | 7 |
| 68462-711-88 | ESTRADIOL VAGINAL INSERTS | 1 in 1 APPLICATOR | TABLET, FILM COATED | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-711 | ESTRADIOL VAGINAL INSERTS (ESTRADIOL) TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240313_86620f6c-fd02-40df-98d5-3048dcd92c37.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 |
|---|
| 68462-711-71 | 68462071171 | 8 APPLICATOR in 1 CARTON (68462-711-71) / 1 TABLET, FILM COATED in 1 APPLICATOR | 8 applicator | 2018-09-17 | 0000-00-00 | No | No | Current |
| 68462-711-88 | 68462071188 | 18 APPLICATOR in 1 CARTON (68462-711-88) / 1 TABLET, FILM COATED in 1 APPLICATOR | 18 applicator | 2018-09-17 | 0000-00-00 | No | No | Current |