Prescription drug · ANDA
EluRyng (Etonogestrel and ethinyl estradiol) NDC 65162-469
Etonogestrel .12 mg/d; Ethinyl estradiol .015 mg/d · Ring · Vaginal · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-469-35 | 6516204693565162046935 | 3 POUCH in 1 CARTON (65162-469-35) / 21 d in 1 POUCH (65162-469-32)Marketed from Dec 16, 2019 |
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)
- EluRyng
- Generic name (nonproprietary)
- etonogestrel and ethinyl estradiol
- Active ingredients
- Etonogestrel — .12 mg/dEthinyl estradiol — .015 mg/d
- Dosage form
- Ring
- Route
- Vaginal
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210830
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 65162-469_f4ebff86-0b26-41a2-9b3f-6bb4dabbe385SPL ID f4ebff86-0b26-41a2-9b3f-6bb4dabbe385SPL set ID c6c8512d-b258-4be5-8c2f-0f1893f198b9RxCUI 1367436, 2266506UNII 304GTH6RNH, 423D2T571U
- Pharmacologic class
- Estrogen; Progestin
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
N465162046935followed by a unit qualifier and the quantityPackage 65162-0469-35. 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)
FOR VAGINAL USE ONLY EluRyng™ is indicated for use by females of reproductive age to prevent pregnancy. EluRyng is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy. (1)
Excerpt only. Read the full label for complete information.
About NDC 65162-469
- What is NDC 65162-469?
- 65162-469 is the product NDC for EluRyng, Etonogestrel .12 mg/d; Ethinyl estradiol .015 mg/d ring, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- EluRyng (Etonogestrel and Ethinyl Estradiol).
- What is the active ingredient?
- Etonogestrel, Ethinyl 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 EluRyng?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.