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 | 7260308740872603087408 | 8 APPLICATOR in 1 CARTON (72603-874-08) / 1 TABLET, FILM COATED in 1 APPLICATORMarketed from Sep 1, 2025 | |
| 72603-874-18 | 7260308741872603087418 | 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 LLCNDC labeler code 72603
- 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Estradiol vaginal inserts are an estrogen indicated for the treatment of atrophic vaginitis due to menopause ( 1.1 ) 1.1 Treatment of Atrophic Vaginitis due to Menopause .
Excerpt only. Read the full label for complete information.
About NDC 72603-874
- What is NDC 72603-874?
- 72603-874 is the product NDC for Estradiol Vaginal Inserts (estradiol), Estradiol hemihydrate 10 ug/1 tablet, film coated, listed with the FDA by NorthStar Rx LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Estradiol Vaginal Inserts (Estradiol).
- What is the active ingredient?
- Estradiol hemihydrate.
- Who is the labeler?
- NorthStar Rx LLC, NDC labeler code 72603. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Estradiol Vaginal Inserts?
- 2 other product NDCs are listed under this name. See all Estradiol Vaginal Inserts NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Estradiol Vaginal Inserts products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Estradiol Vaginal Insertsestradiol | Estradiol hemihydrate 10 ug/1 | Tablet, Film coatedVaginal | Aurobindo Pharma Limited | 59651-439 | 59651-0439-0859651-0439-18 |
| Estradiol Vaginal Insertsestradiol | Estradiol 10 ug/1 | Tablet, Film coatedVaginal | Glenmark Pharmaceuticals Inc., USA | 68462-711 | 68462-0711-7168462-0711-88 |
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 |