Prescription drug · ANDA
Estradiol (estradiol gel 0.1%) NDC 70700-195
Estradiol 1.25 mg/1.25g · Gel · Topical · Xiromed, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-195-35 | 70700019535 | 30 PACKET in 1 CARTON (70700-195-35) / 1.25 g in 1 PACKETMarketed from Oct 1, 2022 |
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 gel 0.1%
- Active ingredients
- Estradiol — 1.25 mg/1.25g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Xiromed, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211783
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70700-195_5729f205-db48-4ed1-3b2d-190fef4ad81eSPL ID 5729f205-db48-4ed1-3b2d-190fef4ad81eSPL set ID 1a46efe6-21b9-3f0f-90b9-59f279ef51dfRxCUI 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
N470700019535followed by a unit qualifier and the quantityPackage 70700-0195-35. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 211783
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 |
|---|---|---|---|---|
| Estradiolestradiol gel 0.1% | Estradiol .25 mg/.25g | GelTopical | Xiromed, LLC | 70700-143 |
| Estradiolestradiol gel 0.1% | Estradiol .5 mg/.5g | GelTopical | Xiromed, LLC | 70700-144 |
| Estradiolestradiol gel 0.1% | Estradiol 1 mg/g | GelTopical | Xiromed, LLC | 70700-145 |
| Estradiolestradiol gel 0.1% | Estradiol .75 mg/.75g | GelTopical | Xiromed, LLC | 70700-194 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.