Prescription drug · ANDA
Estradiol Vaginal Inserts (Estradiol) NDC 68462-711
Estradiol 10 ug/1 · Tablet, Film coated · Vaginal · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-711-71 | 68462071171 | 8 APPLICATOR in 1 CARTON (68462-711-71) / 1 TABLET, FILM COATED in 1 APPLICATORMarketed from Sep 17, 2018 | |
| 68462-711-88 | 68462071188 | 18 APPLICATOR in 1 CARTON (68462-711-88) / 1 TABLET, FILM COATED in 1 APPLICATORMarketed from Sep 17, 2018 |
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 — 10 ug/1
- Dosage form
- Tablet, Film coated
- Route
- Vaginal
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210264
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68462-711_732fcf7c-ebfa-4c6d-a06e-5e2ed8d90ef7SPL ID 732fcf7c-ebfa-4c6d-a06e-5e2ed8d90ef7SPL set ID 86620f6c-fd02-40df-98d5-3048dcd92c37RxCUI 884707UNII 4TI98Z838EUPC 0368462711880, 0368462711712
- 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
N468462071171followed by a unit qualifier and the quantityPackage 68462-0711-71. 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 68462-711
- What is NDC 68462-711?
- 68462-711 is the product NDC for Estradiol Vaginal Inserts (estradiol), Estradiol 10 ug/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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.
- Who is the labeler?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 hemihydrate 10 ug/1 | Tablet, Film coatedVaginal | Aurobindo Pharma Limited | 59651-439 | 59651-0439-0859651-0439-18 |