Prescription drug · ANDA
Estradiol NDC 45802-310
Estradiol .75 mg/.75g · Gel · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-310-30 | 45802031030 | 30 PACKET in 1 CARTON (45802-310-30) / .75 g in 1 PACKETMarketed from Dec 7, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Estradiol
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — .75 mg/.75g
- Dosage form
- Gel
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216524
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 45802-310_f9b29b00-b229-45cc-91b5-e7df87f857d1SPL ID f9b29b00-b229-45cc-91b5-e7df87f857d1SPL set ID 3ac905b3-904c-4285-97ed-e787d006c7ddRxCUI 2619677, 2619679, 2619681, 2619683, 2619685UNII 4TI98Z838E
- Pharmacologic class
- Estrogen
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N445802031030followed by a unit qualifier and the quantityPackage 45802-0310-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Estradiol gel is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ). 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216524
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Estradiol | Estradiol .25 mg/.25g | GelTopical | Bryant Ranch Prepack | 72162-2290 |
| Estradiol | Estradiol .5 mg/.5g | GelTopical | Bryant Ranch Prepack | 72162-2291 |
| Estradiol | Estradiol .75 mg/.75g | GelTopical | Bryant Ranch Prepack | 72162-2292 |
| Estradiol | Estradiol 1 mg/g | GelTopical | Bryant Ranch Prepack | 72162-2293 |
| Estradiol | Estradiol .25 mg/.25g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-134 |
| Estradiol | Estradiol .5 mg/.5g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-202 |
| Estradiol | Estradiol 1 mg/g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-452 |
| Estradiol | Estradiol 1.25 mg/1.25g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-573 |