ESTRADIOL VAGINAL INSERTS
- Product NDC
- 59651-439
- 11-digit product format
- 596510439
- Labeler code
- 59651
- Product ID
- 59651-439_2df3b31e-32a6-49cd-a636-5b7779a5ed0c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- TABLET, FILM COATED
- Route
- VAGINAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA216550
- Marketing category
- ANDA
- Marketing start
- 2024-08-02
- Substance
- ESTRADIOL HEMIHYDRATE
- Active strength
- 10 ug/1
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| CXY7B3Q98Z | ESTRADIOL HEMIHYDRATE | 35380-71-3 | ESTRADIOL HEMIHYDRATE |
| 4TI98Z838E | ESTRADIOL | 50-28-2 | Estradiol |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-439-08 | 59651043908 | 8 APPLICATOR in 1 CARTON (59651-439-08) / 1 TABLET, FILM COATED in 1 APPLICATOR | 8 applicator | 2024-08-02 | No | No | Historical |
| 59651-439-18 | 59651043918 | 18 APPLICATOR in 1 CARTON (59651-439-18) / 1 TABLET, FILM COATED in 1 APPLICATOR | 18 applicator | 2024-08-02 | No | No | Historical |