Estradiol Vaginal
- Product NDC
- 45802-097
- 11-digit product format
- 458020097
- Labeler code
- 45802
- Product ID
- 45802-097_e656010f-9ad1-4a86-89c7-2315c4b0ec44
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA210194
- Marketing category
- ANDA
- Marketing start
- 2021-01-06
- Substance
- ESTRADIOL
- Active strength
- .1 mg/g
- 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 Vaginal
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | .1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E |
| Rxcui | 310169 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-097-35 | Estradiol Vaginal | 1 in 1 CARTON | CREAM | 1 | | 11 |
| 45802-097-35 | Estradiol Vaginal | 42.5 g in 1 TUBE | CREAM | 42.5 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-097 | ESTRADIOL VAGINAL (ESTRADIOL) CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240627_f76232ed-b109-43d1-bf2e-d41b6420c37d.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 |
|---|
| 45802-097-35 | 45802009735 | 1 TUBE in 1 CARTON (45802-097-35) / 42.5 g in 1 TUBE | 1 tube | 2021-01-06 | 0000-00-00 | No | No | Current |