Estradiol
- Product NDC
- 13811-092
- 11-digit product format
- 138110092
- Labeler code
- 13811
- Product ID
- 13811-092_248c5ced-1972-443a-8cb0-de1e9ab011be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Trigen Laboratories, LLC
- Application
- NDA022038
- Marketing category
- NDA
- Marketing start
- 2022-10-10
- Substance
- ESTRADIOL
- Active strength
- .75 mg/.75g
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | .75 mg/.75g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E |
| Rxcui | 2619677, 2619679, 2619681, 2619683, 2619685 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13811-092-32 | Estradiol | 30 in 1 CARTON | GEL | 30 | | 8 |
| 13811-092-32 | Estradiol | 0.75 g in 1 PACKET | GEL | 0.75 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13811-092 | ESTRADIOL GEL [TRIGEN LABORATORIES, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240725_e84ad638-6768-41aa-b2b8-e2514ef63881.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 |
|---|
| 13811-092-32 | 13811009232 | 30 PACKET in 1 CARTON (13811-092-32) / .75 g in 1 PACKET | 30 packet | 2022-10-10 | 0000-00-00 | No | No | Current |