Estradiol
- Product NDC
- 70700-194
- 11-digit product format
- 707000194
- Labeler code
- 70700
- Product ID
- 70700-194_6bb1aab9-ed96-51da-0e8a-b87af5450fdd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol Gel 0.1%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Xiromed, LLC
- Application
- ANDA211783
- Marketing category
- ANDA
- Marketing start
- 2022-10-01
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70700-194-35 | Estradiol | 30 in 1 CARTON | GEL | 30 | | 9 |
| 70700-194-35 | Estradiol | 0.75 g in 1 PACKET | GEL | 0.75 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70700-194 | ESTRADIOL (ESTRADIOL GEL 0.1%) GEL [XIROMED, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240517_1a46efe6-21b9-3f0f-90b9-59f279ef51df.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70700-194-35 | 70700019435 | 30 PACKET in 1 CARTON (70700-194-35) / .75 g in 1 PACKET | 30 packet | 2022-10-01 | 0000-00-00 | No | No | Current |