ESTRADIOL
- Product NDC
- 76420-023
- 11-digit product format
- 764200023
- Labeler code
- 76420
- Product ID
- 76420-023_2e001c04-6c12-6e69-e063-6294a90ac950
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESTRADIOL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA040275
- Marketing category
- ANDA
- Marketing start
- 2017-04-10
- Substance
- ESTRADIOL
- Active strength
- 2 mg/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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E |
| Rxcui | 197657, 197658, 197659 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-023-30 | ESTRADIOL | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 76420-023-90 | ESTRADIOL | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
| 76420-023-10 | ESTRADIOL | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-023 | ESTRADIOL TABLET [ASCLEMED USA, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250215_487ce40e-1f13-4497-994a-c5d91b87b6cc.zip |
| 76420-023 | ESTRADIOL TABLET [ASCLEMED USA, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20221013_229b4ec5-d3c8-4406-9fc5-8f633c6447b8.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 |
|---|
| 76420-023-10 | 76420002310 | 100 TABLET in 1 BOTTLE (76420-023-10) | 100 tablet | 2020-09-29 | 0000-00-00 | No | No | Current |
| 76420-023-30 | 76420002330 | 30 TABLET in 1 BOTTLE (76420-023-30) | 30 tablet | 2019-12-16 | 0000-00-00 | No | No | Current |
| 76420-023-90 | 76420002390 | 90 TABLET in 1 BOTTLE (76420-023-90) | 90 tablet | 2019-12-16 | 0000-00-00 | No | No | Current |