Estradiol Vaginal
- Product NDC
- 68071-3796
- 11-digit product format
- 680713796
- Labeler code
- 68071
- Product ID
- 68071-3796_2e5a4d85-1780-b878-e063-6394a90a4caa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Estradiol Vaginal
- Listing expiration
- 2026-12-31
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 |
|---|
| 68071-3796-4 | Estradiol Vaginal | 42.5 g in 1 TUBE | CREAM | 42.5 | | 1 |
| 68071-3796-4 | Estradiol Vaginal | 1 in 1 CARTON | CREAM | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3796 | ESTRADIOL VAGINAL (ESTRADIOL) CREAM [NUCARE PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20250221_2e5a4d78-6683-4fb8-e063-6294a90a49e7.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 |
|---|
| 68071-3796-4 | 68071379604 | 1 TUBE in 1 CARTON (68071-3796-4) / 42.5 g in 1 TUBE | 1 tube | 2025-02-17 | No | No | Historical |