Prescription drug · ANDA
Ashlyna NDC 68462-646
levonorgestrel and ethinyl estradiol and ethinyl estradiol · Kit · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-646-93 | 68462064693 | 2 POUCH in 1 CARTON (68462-646-93) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK (68462-646-91)Marketed from Feb 23, 2015 |
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)
- Ashlyna
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol and ethinyl estradiol
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203163
- Marketing start
- Listing expires
- Identifiers
- Product ID 68462-646_8ba0405a-4148-4c5c-80f1-28c73ebb41a7SPL ID 8ba0405a-4148-4c5c-80f1-28c73ebb41a7SPL set ID 407a9f63-9abf-4886-864a-d3dd0e429762RxCUI 238019, 248310, 749761, 1603861UPC 0368462646915
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
N468462064693followed by a unit qualifier and the quantityPackage 68462-0646-93. 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)
Ashlynais indicated for use by females of reproductive potential to prevent pregnancy. Ashlyna is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203163
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 |
|---|---|---|---|---|
| Ashlynalevonorgestrel and ethinyl estradiol and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-2097 |