Prescription drug · ANDA
Estradiol NDC 72603-242
Estradiol .5 mg/.5g · Gel · Topical · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-242-30 | 72603024230 | 30 PACKET in 1 CARTON (72603-242-30) / .5 g in 1 PACKET (72603-242-01)Marketed from Dec 18, 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 — .5 mg/.5g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- NorthStar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217610
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72603-242_37b3aa97-b1e5-fe8e-e063-6294a90a48c4SPL ID 37b3aa97-b1e5-fe8e-e063-6294a90a48c4SPL set ID 0c8a07a4-5762-eaf4-e063-6394a90a54ffRxCUI 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
N472603024230followed by a unit qualifier and the quantityPackage 72603-0242-30. 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)
1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Estradiol gel is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause (1.1).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217610
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 | NorthStar Rx LLC | 72603-241 |
| Estradiol | Estradiol 1.25 mg/1.25g | GelTopical | NorthStar Rx LLC | 72603-245 |
| Estradiol | Estradiol .75 mg/.75g | GelTopical | NorthStar Rx LLC | 72603-243 |
| Estradiol | Estradiol 1 mg/g | GelTopical | NorthStar Rx LLC | 72603-244 |
| Estradiol | Estradiol .25 mg/.25g | GelTopical | ANI Pharmaceuticals, Inc. | 70954-531 |
| Estradiol | Estradiol .5 mg/.5g | GelTopical | ANI Pharmaceuticals, Inc. | 70954-530 |
| Estradiol | Estradiol 1.25 mg/1.25g | GelTopical | ANI Pharmaceuticals, Inc. | 70954-534 |
| Estradiol | Estradiol .75 mg/.75g | GelTopical | ANI Pharmaceuticals, Inc. | 70954-532 |
| Estradiol | Estradiol 1 mg/g | GelTopical | ANI Pharmaceuticals, Inc. | 70954-533 |