Prescription drug · ANDA
Sronyx (Levonorgestrel and ethinyl estradiol) NDC 51862-545
Kit · Mayne Pharma Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Sronyx
- 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 077681
- Marketing start
- Listing expires
- Identifiers
- Product ID 51862-545_3aadfd82-3d97-6e99-e063-6294a90a958eSPL ID 3aadfd82-3d97-6e99-e063-6294a90a958eSPL set ID b0c1a495-4cd7-4664-8fe4-714812f53c71RxCUI 242297, 748797, 748868, 753544
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 . This label includes a boxed warning.
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 III 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table III Percentage of women experiencing an unintended pregnancy during the first year of typical use and first year of perfect use of contraception and the percentage …
Excerpt only. Read the full label for complete information.
About NDC 51862-545
- What is NDC 51862-545?
- 51862-545 is the product NDC for Sronyx kit, listed with the FDA by Mayne Pharma Inc..
- What drug is associated with this NDC?
- Sronyx (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 Sronyx?
- 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.