Prescription drug · ANDA
Ayuna (Levonorgestrel and ethinyl estradiol) NDC 65862-848
Kit · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-848-88 | 6586208488865862084888 | 3 POUCH in 1 CARTON (65862-848-88) / 1 BLISTER PACK in 1 POUCH (65862-848-28) / 1 KIT in 1 BLISTER PACKMarketed from Sep 23, 2016 | |
| 65862-848-92 | 6586208489265862084892 | 6 POUCH in 1 CARTON (65862-848-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Sep 23, 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)
- Ayuna
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206866
- Marketing start
- Listing expires
- Identifiers
- Product ID 65862-848_079e52df-9a18-4482-9bbe-3f63dbb96b9eSPL ID 079e52df-9a18-4482-9bbe-3f63dbb96b9eSPL set ID 2b54ce42-db64-46c3-a788-569e21f7ab06RxCUI 238019, 748797, 748878, 1812279
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
N465862084888followed by a unit qualifier and the quantityPackage 65862-0848-88. 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)
INDICATIONS AND USAGE Ayuna is indicated for use by females of reproductive potential to prevent pregnancy.
Excerpt only. Read the full label for complete information.
About NDC 65862-848
- What is NDC 65862-848?
- 65862-848 is the product NDC for Ayuna kit, 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?
- Ayuna (Levonorgestrel and Ethinyl Estradiol).
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ayuna?
- 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.
Other NDCs under ANDA 206866
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 |
|---|---|---|---|---|
| Chateal EQlevonorgestrel and ethinyl estradiol | — | Kit | Afaxys Pharma, LLC | 50102-230 |