Prescription drug · ANDA
Estradiol Vaginal Inserts (Estradiol) NDC 59651-439
Estradiol hemihydrate 10 ug/1 · Tablet, Film coated · Vaginal · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-439-08 | 5965104390859651043908 | 8 APPLICATOR in 1 CARTON (59651-439-08) / 1 TABLET, FILM COATED in 1 APPLICATORMarketed from Aug 2, 2024 | |
| 59651-439-18 | 5965104391859651043918 | 18 APPLICATOR in 1 CARTON (59651-439-18) / 1 TABLET, FILM COATED in 1 APPLICATORMarketed from Aug 2, 2024 |
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
- Aurobindo Pharma LimitedNDC labeler code 59651
- 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 59651-439_2df3b31e-32a6-49cd-a636-5b7779a5ed0cSPL ID 2df3b31e-32a6-49cd-a636-5b7779a5ed0cSPL set ID 6247e329-e20e-4ea5-9cc1-b593bd494577RxCUI 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
N459651043908followed by a unit qualifier and the quantityPackage 59651-0439-08. 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 59651-439
- What is NDC 59651-439?
- 59651-439 is the product NDC for Estradiol Vaginal Inserts (estradiol), Estradiol hemihydrate 10 ug/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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 | NorthStar Rx LLC | 72603-874 | 72603-0874-0872603-0874-18 |
| 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 | NorthStar Rx LLC | 72603-874 |