ESTRADIOL
- Product NDC
- 21922-015
- 11-digit product format
- 219220015
- Labeler code
- 21922
- Product ID
- 21922-015_d03184c7-c726-4356-a643-bd4bdd0f893b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- GEL
- Route
- TRANSDERMAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA218214
- Marketing category
- ANDA
- Marketing start
- 2026-05-13
- Substance
- ESTRADIOL
- Active strength
- .75 mg/1.25g
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ESTRADIOL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | .75 mg/1.25g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E |
| Rxcui | 226597 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21922-015-40 | ESTRADIOL | 50 g in 1 BOTTLE, PUMP | GEL | 50 | | 3 |
| 21922-015-40 | ESTRADIOL | 1 in 1 CARTON | GEL | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 21922-015-40 | 21922001540 | 1 BOTTLE, PUMP in 1 CARTON (21922-015-40) / 50 g in 1 BOTTLE, PUMP | 2026-05-13 | No | No | Current |