Prescription drug · ANDA
Lutera (Levonorgestrel and ethinyl estradiol) NDC 51862-028
Kit · Mayne Pharma Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Lutera
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Mayne Pharma Inc.NDC labeler code 51862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076625
- Marketing start
- Listing expires
- Identifiers
- Product ID 51862-028_bf6c876c-12de-48e8-a9f2-cf74ee3338f1SPL ID bf6c876c-12de-48e8-a9f2-cf74ee3338f1SPL set ID b91ad328-f2f4-4f7d-82d3-daaada95f509RxCUI 242297, 748797, 748868, 751884
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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Lutera is indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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, the IUD, and Norplant ® System, 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 Typical Use And The First Year Of Perfect Use Of Contr…
Excerpt only. Read the full label for complete information.
About NDC 51862-028
- What is NDC 51862-028?
- 51862-028 is the product NDC for Lutera kit, listed with the FDA by Mayne Pharma Inc..
- What drug is associated with this NDC?
- Lutera (Levonorgestrel and ethinyl estradiol).
- Who is the labeler?
- Mayne Pharma Inc., NDC labeler code 51862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lutera?
- 1 other product NDC are listed under this name. See all Lutera NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lutera products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Luteralevonorgestrel and ethinyl estradiol | — | Kit | Dr. Reddys Laboratories Inc. | 55741-005 | 55741-0005-0655741-0005-28 |