Prescription drug · ANDA
Estradiol NDC 70954-534
Estradiol 1.25 mg/1.25g · Gel · Topical · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-534-20 | 70954053420 | 30 PACKET in 1 CARTON (70954-534-20) / 1.25 g in 1 PACKET (70954-534-10)Marketed from Aug 24, 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 — 1.25 mg/1.25g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- ANI Pharmaceuticals, Inc.
- 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 70954-534_9632833e-75b0-4164-ae9a-be4857edd8dbSPL ID 9632833e-75b0-4164-ae9a-be4857edd8dbSPL set ID ff28c624-906d-459c-8b8c-27cb1a664e12RxCUI 2619677, 2619679, 2619681, 2619683, 2619685UNII 4TI98Z838EUPC 0370954531104, 0370954530107, 0370954532101, 0370954534105, 0370954533108
- 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
N470954053420followed by a unit qualifier and the quantityPackage 70954-0534-20. 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 .5 mg/.5g | GelTopical | NorthStar Rx LLC | 72603-242 |
| 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 .75 mg/.75g | GelTopical | ANI Pharmaceuticals, Inc. | 70954-532 |
| Estradiol | Estradiol 1 mg/g | GelTopical | ANI Pharmaceuticals, Inc. | 70954-533 |