Estradiol
- Product NDC
- 70954-533
- 11-digit product format
- 709540533
- Labeler code
- 70954
- Product ID
- 70954-533_98963341-a7e0-4b8d-bb56-be1820611090
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA217610
- Marketing category
- ANDA
- Marketing start
- 2023-08-24
- 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
- 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 | 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 |
|---|
| 70954-533-10 | Estradiol | 1 g in 1 PACKET | GEL | 1 | | 5 |
| 70954-533-20 | Estradiol | 30 in 1 CARTON | GEL | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-533 | ESTRADIOL GEL [ANI PHARMACEUTICALS, INC.] | 3 | Current NDC, 2 package rows | 20240427_ff28c624-906d-459c-8b8c-27cb1a664e12.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 |
|---|
| 70954-533-10 | 70954053310 | 1 g in 1 PACKET | 1 g | | | | Historical |
| 70954-533-20 | 70954053320 | 30 PACKET in 1 CARTON (70954-533-20) / 1 g in 1 PACKET (70954-533-10) | 30 packet | 2023-08-24 | No | No | Historical |