Estradiol
- Product NDC
- 70954-646
- 11-digit product format
- 709540646
- Labeler code
- 70954
- Product ID
- 70954-646_3518120e-cc44-4d70-8a20-0ef2dce9a3c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- GEL, METERED
- Route
- TOPICAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA217882
- Marketing category
- ANDA
- Marketing start
- 2024-10-23
- Substance
- ESTRADIOL
- Active strength
- .75 mg/1.25g
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | .75 mg/1.25g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E |
| Rxcui | 226597 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-646-10 | Estradiol | 50 g in 1 BOTTLE, PUMP | GEL, METERED | 50 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-646 | ESTRADIOL GEL, METERED [ANI PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20241030_3518120e-cc44-4d70-8a20-0ef2dce9a3c6.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 |
|---|
| 70954-646-10 | 70954064610 | 50 g in 1 BOTTLE, PUMP (70954-646-10) | 50 g | 2024-10-23 | No | No | Historical |