Prescription drug · NDA
NuvaRing NDC 78206-146
etonogestrel and ethinyl estradiol · Etonogestrel .12 mg/d; Ethinyl estradiol .015 mg/d · Insert, Extended release · Vaginal · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-146-03 | 78206014603 | 3 POUCH in 1 BOX (78206-146-03) / 21 d in 1 POUCH (78206-146-01)Marketed from Jun 1, 2021 |
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)
- NuvaRing
- Generic name (nonproprietary)
- etonogestrel and ethinyl estradiol
- Active ingredients
- Etonogestrel — .12 mg/dEthinyl estradiol — .015 mg/d
- Dosage form
- Insert, Extended release
- Route
- Vaginal
- Labeler
- Organon LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021187
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 78206-146_10ea7737-88e0-4b3b-9741-d67fb521e3d1SPL ID 10ea7737-88e0-4b3b-9741-d67fb521e3d1SPL set ID 55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d97RxCUI 1367436, 1367439UNII 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
N478206014603followed by a unit qualifier and the quantityPackage 78206-0146-03. 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 NuvaRing ® is indicated for use by females of reproductive age to prevent pregnancy. NuvaRing 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.
Other NDCs under NDA 021187
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 |
|---|---|---|---|---|
| Nuvaringetonogestrel and ethinyl estradiol | Etonogestrel .12 mg/d; Ethinyl estradiol .015 mg/d | Insert, Extended releaseVaginal | A-S Medication Solutions | 50090-7663 |
| Etonogestrel/Ethinyl Estradioletonogestrel and ethinyl estradiol | Etonogestrel .12 mg/d; Ethinyl estradiol .015 mg/d | Insert, Extended releaseVaginal | A-S Medication Solutions | 50090-5959 |
| Nuvaringetonogestrel and ethinyl estradiol | Etonogestrel .12 mg/d; Ethinyl estradiol .015 mg/d | Insert, Extended releaseVaginal | A-S Medication Solutions | 50090-5611 |
| NuvaRingetonogestrel and ethinyl estradiol | Etonogestrel .12 mg/d; Ethinyl estradiol .015 mg/d | Insert, Extended releaseVaginal | Advanz Pharma (US) Corp. | 59212-146 |
| Etonogestrel/Ethinyl Estradioletonogestrel and ethinyl estradiol | Etonogestrel .12 mg/d; Ethinyl estradiol .015 mg/d | Insert, Extended releaseVaginal | Prasco Laboratories | 66993-605 |