ESTRACE
- Product NDC
- 50090-2321
- 11-digit product format
- 500902321
- Labeler code
- 50090
- Product ID
- 50090-2321_d0bdce5c-be19-4bfa-bc55-9682f516ea87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA086069
- Marketing category
- ANDA
- Marketing start
- 2001-07-01
- 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
- ESTRACE
- 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, 890918 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-2321-0 | ESTRACE | 1 in 1 CARTON | CREAM | 1 | | 20 |
| 50090-2321-0 | ESTRACE | 42.5 g in 1 TUBE | CREAM | 42.5 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-2321 | ESTRACE (ESTRADIOL) CREAM [A-S MEDICATION SOLUTIONS] | 20 | Current NDC, Legacy NDC, 2 package rows | 20240813_da52a602-f2a2-4382-be07-30351c58cc4b.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 |
|---|
| 50090-2321-0 | 50090232100 | 1 TUBE in 1 CARTON (50090-2321-0) / 42.5 g in 1 TUBE | 1 tube | 2016-03-02 | 0000-00-00 | No | No | Current |