Prescription drug · ANDA
Estradiol Vaginal Inserts (estradiol) NDC 72603-874
Estradiol hemihydrate 10 ug/1 · Tablet, Film coated · Vaginal · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-874-08 | 72603087408 | 8 APPLICATOR in 1 CARTON (72603-874-08) / 1 TABLET, FILM COATED in 1 APPLICATORMarketed from Sep 1, 2025 | |
| 72603-874-18 | 72603087418 | 18 APPLICATOR in 1 CARTON (72603-874-18) / 1 TABLET, FILM COATED in 1 APPLICATORMarketed from Sep 1, 2025 |
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 Vaginal Inserts
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol hemihydrate — 10 ug/1
- Dosage form
- Tablet, Film coated
- Route
- Vaginal
- Labeler
- NorthStar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216550
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72603-874_ad203bfd-28da-45a3-b9c0-7f886eb03634SPL ID ad203bfd-28da-45a3-b9c0-7f886eb03634SPL set ID ad203bfd-28da-45a3-b9c0-7f886eb03634RxCUI 884707UNII CXY7B3Q98Z
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N472603087408followed by a unit qualifier and the quantityPackage 72603-0874-08. 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 216550
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 Vaginal Insertsestradiol | Estradiol hemihydrate 10 ug/1 | Tablet, Film coatedVaginal | Aurobindo Pharma Limited | 59651-439 |