ESTRADIOL VAGINAL
- Product NDC
- 21922-085
- 11-digit product format
- 219220085
- Labeler code
- 21922
- Product ID
- 21922-085_1c61e837-4196-4b4d-9545-96b2d7c66f13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA209767
- Marketing category
- ANDA
- Marketing start
- 2025-08-14
- Substance
- ESTRADIOL HEMIHYDRATE
- Active strength
- .1 mg/g
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL HEMIHYDRATE | .1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CXY7B3Q98Z |
| Rxcui | 310169 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21922-085-06 | ESTRADIOL VAGINAL | 1 in 1 CARTON | CREAM | 1 | | 1 |
| 21922-085-06 | ESTRADIOL VAGINAL | 42.5 g in 1 TUBE | CREAM | 42.5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 21922-085-06 | 21922008506 | 1 TUBE in 1 CARTON (21922-085-06) / 42.5 g in 1 TUBE | 1 tube | 2025-08-14 | No | No | Current |