Estradiol
- Product NDC
- 63629-8713
- 11-digit product format
- 636298713
- Labeler code
- 63629
- Product ID
- 63629-8713_06e2b88b-16e5-4926-bc67-7ca1c1f9156f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209767
- Marketing category
- ANDA
- Marketing start
- 2018-03-05
- 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
- 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 |
|---|
| 63629-8713-1 | Estradiol | 42.5 g in 1 TUBE, WITH APPLICATOR | CREAM | 42.5 | | 106 |
| 63629-8713-1 | Estradiol | 1 in 1 CARTON | CREAM | 1 | | 106 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8713 | ESTRADIOL CREAM [BRYANT RANCH PREPACK] | 106 | Current NDC, Legacy NDC, 2 package rows | 20240901_74baff07-15df-48a8-93b8-3a317f896a56.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8713-1 | 63629871301 | 1 TUBE, WITH APPLICATOR in 1 CARTON (63629-8713-1) / 42.5 g in 1 TUBE, WITH APPLICATOR | 2021-08-19 | 0000-00-00 | No | No | Current |