Prescription drug · ANDA
Yuvafem (Estradiol) NDC 65162-226
Estradiol 10 ug/1 · Tablet · Vaginal · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-226-21 | 65162022621 | 8 APPLICATOR in 1 CARTON (65162-226-21) / 1 TABLET in 1 APPLICATORMarketed from Oct 17, 2016 | |
| 65162-226-23 | 65162022623 | 18 APPLICATOR in 1 CARTON (65162-226-23) / 1 TABLET in 1 APPLICATORMarketed from Oct 17, 2016 |
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)
- Yuvafem
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — 10 ug/1
- Dosage form
- Tablet
- Route
- Vaginal
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205256
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 65162-226_b3543f3c-816d-46c4-b9e0-b706d4b1f425SPL ID b3543f3c-816d-46c4-b9e0-b706d4b1f425SPL set ID 30c7f6ba-7a9e-4853-b3e4-e00a46560224RxCUI 884707, 1797113UNII 4TI98Z838EUPC 0365162226218
- 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
N465162022621followed by a unit qualifier and the quantityPackage 65162-0226-21. 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)
Yuvafem is an estrogen (estradiol) 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 65162-226
- What is NDC 65162-226?
- 65162-226 is the product NDC for Yuvafem (estradiol), Estradiol 10 ug/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Yuvafem (Estradiol).
- What is the active ingredient?
- Estradiol.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Yuvafem?
- 1 other product NDC are listed under this name. See all Yuvafem NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Yuvafem products
Other finished products listed under the same name: strengths, forms and labelers.
Other NDCs under ANDA 205256
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 | Estradiol 10 ug/1 | InsertVaginal | Amneal Pharmaceuticals of New York LLC | 53746-226 |
| Yuvafemestradiol | Estradiol 10 ug/1 | TabletVaginal | AvKARE | 42291-962 |