Estradiol
- Product NDC
- 53746-226
- 11-digit product format
- 537460226
- Labeler code
- 53746
- Product ID
- 53746-226_eb2cbf77-ea3e-4604-9271-cd2228059e30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- INSERT
- Route
- VAGINAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA205256
- Marketing category
- ANDA
- Marketing start
- 2015-06-07
- 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
- 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 |
|---|
| 53746-226-21 | Estradiol | 1 in 1 APPLICATOR | INSERT | 1 | | 14 |
| 53746-226-21 | Estradiol | 8 in 1 CARTON | INSERT | 8 | | 14 |
| 53746-226-23 | Estradiol | 1 in 1 APPLICATOR | INSERT | 1 | | 14 |
| 53746-226-23 | Estradiol | 18 in 1 CARTON | INSERT | 18 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-226 | ESTRADIOL INSERT [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 14 | Current NDC, Legacy NDC, 4 package rows | 20250108_094830ee-1b1c-4cf7-8a39-427dfd56f9c9.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 |
|---|
| 53746-226-21 | 53746022621 | 8 APPLICATOR in 1 CARTON (53746-226-21) / 1 INSERT in 1 APPLICATOR | 8 applicator | 2015-06-07 | 0000-00-00 | No | No | Current |
| 53746-226-23 | 53746022623 | 18 APPLICATOR in 1 CARTON (53746-226-23) / 1 INSERT in 1 APPLICATOR | 18 applicator | 2015-06-07 | 0000-00-00 | No | No | Current |