Prescription drug · ANDA
Viorele NDC 50090-1395
desogestrel and ethinyl estradiol and ethinyl estradiol · Kit · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1395-0 | 50090139500 | 1 KIT in 1 KIT (50090-1395-0)Marketed from Nov 28, 2014 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Viorele
- Generic name (nonproprietary)
- desogestrel and ethinyl estradiol and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091346
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-1395_5fa87371-f59b-4042-995f-ea88f04246c1SPL ID 5fa87371-f59b-4042-995f-ea88f04246c1SPL set ID 6422dcc3-959a-4590-9ca8-9dcb58e68253RxCUI 248310, 249357, 748797, 759743, 1252016
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
N450090139500followed by a unit qualifier and the quantityPackage 50090-1395-00. 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.
Other NDCs under ANDA 091346
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 |
|---|---|---|---|---|
| Vioreledesogestrel and ethinyl estradiol and ethinyl estradiol | — | Kit | Glenmark Pharmaceuticals Inc., USA | 68462-318 |