Estradiol
- Product NDC
- 70954-566
- 11-digit product format
- 709540566
- Labeler code
- 70954
- Product ID
- 70954-566_6b381113-0e63-42e0-aeb7-d339e798f444
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA217334
- Marketing category
- ANDA
- Marketing start
- 2023-09-06
- 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 |
|---|
| 70954-566-10 | Estradiol | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 70954-566-20 | Estradiol | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-566 | ESTRADIOL TABLET [ANI PHARMACEUTICALS, INC.] | 2 | Current NDC, 2 package rows | 20240926_3fe899db-a8cd-4a31-88fb-1129be96b4d9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70954-566-10 | 70954056610 | 100 TABLET in 1 BOTTLE (70954-566-10) | 100 tablet | 2023-09-06 | No | No | Historical |
| 70954-566-20 | 70954056620 | 500 TABLET in 1 BOTTLE (70954-566-20) | 500 tablet | 2023-09-06 | No | No | Historical |