ESTRADIOL
- Product NDC
- 45802-452
- 11-digit product format
- 458020452
- Labeler code
- 45802
- Product ID
- 45802-452_f9b29b00-b229-45cc-91b5-e7df87f857d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA216524
- Marketing category
- ANDA
- Marketing start
- 2023-12-07
- 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
- 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 |
|---|---|
| ESTRADIOL | 1 mg/g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4TI98Z838E |
| Rxcui | 2619677, 2619679, 2619681, 2619683, 2619685 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45802-452-30 | ESTRADIOL | 30 in 1 CARTON | GEL | 30 | 25 | |
| 45802-452-30 | ESTRADIOL | 1 g in 1 PACKET | GEL | 1 | 25 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45802-452-30 | GM - Gram | 45802-452 | 097d99da-91ba-45ad-8e07-d4d2e17dde8f | 1 | 2024-02-14 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2619677 | estradiol 0.1 % (0.25MG / 0.25GM) Transdermal Gel | PSN | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619679 | estradiol 0.1 % (0.5MG / 0.5GM) Transdermal Gel | PSN | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619681 | estradiol 0.1 % (0.75MG / 0.75GM) Transdermal Gel | PSN | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619685 | estradiol 0.1 % (1.25MG / 1.25GM) Transdermal Gel | PSN | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619683 | estradiol 0.1 % (1MG / 1GM) Transdermal Gel | PSN | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619683 | 1000 MG estradiol 0.001 MG/MG Topical Gel | SCD | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619685 | 1250 MG estradiol 0.001 MG/MG Topical Gel | SCD | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619677 | 250 MG estradiol 0.001 MG/MG Topical Gel | SCD | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619679 | 500 MG estradiol 0.001 MG/MG Topical Gel | SCD | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619681 | 750 MG estradiol 0.001 MG/MG Topical Gel | SCD | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619677 | estradiol 0.1 % Transdermal Gel, 0.25 GM | SY | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619679 | estradiol 0.1 % Transdermal Gel, 0.5 GM | SY | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619681 | estradiol 0.1 % Transdermal Gel, 0.75 GM | SY | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619683 | estradiol 0.1 % Transdermal Gel, 1 GM | SY | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619685 | estradiol 0.1 % Transdermal Gel, 1.25 GM | SY | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619683 | estradiol 0.1 % (1MG / 1GM) Transdermal Gel | PSN | 0e927450-3f02-4d2f-9235-a255357e8d93 | 1 |
| 2619683 | 1000 MG estradiol 0.001 MG/MG Topical Gel | SCD | 0e927450-3f02-4d2f-9235-a255357e8d93 | 1 |
| 2619683 | estradiol 0.1 % Transdermal Gel, 1 GM | SY | 0e927450-3f02-4d2f-9235-a255357e8d93 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 45802-452-30 | 45802045230 | 30 PACKET in 1 CARTON (45802-452-30) / 1 g in 1 PACKET | 30 packet | 2023-12-07 | No | No | Current |