Prescription drug · ANDA
Levonest NDC 50090-2505
levonorgestrel and ethinyl estradiol · Kit · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-2505-0 | 50090250500 | 1 KIT in 1 KIT (50090-2505-0)Marketed from Oct 13, 2016 |
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)
- Levonest
- Generic name (nonproprietary)
- levonorgestrel 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 090719
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-2505_9d2a8723-9b52-4445-b3bc-82282791e1f4SPL ID 9d2a8723-9b52-4445-b3bc-82282791e1f4SPL set ID dfda3568-b626-4194-b0af-df5d2ea69e3fRxCUI 310230, 348804, 348805, 748797, 748832, 1095227
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
N450090250500followed by a unit qualifier and the quantityPackage 50090-2505-00. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD Method Perfect Use Typical Use Levono…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090719
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 |
|---|---|---|---|---|
| Levonestlevonorgestrel and ethinyl estradiol | — | Kit | Northstar Rx LLC | 16714-340 |