Prescription drug · ANDA
Levora (Levonorgestrel and ethinyl estradiol) NDC 51862-097
Kit · Mayne Pharma Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)51862-097Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51862-0097Add the package segment from the table below.
Product information
- Brand name (proprietary)
- Levora
- 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 073594
- Marketing start
- Listing expires
- Identifiers
- Product ID 51862-097_3aadc382-e2a4-019e-e063-6394a90a45c3SPL ID 3aadc382-e2a4-019e-e063-6394a90a45c3SPL set ID 31679b9f-58c9-4bf1-8c2c-f5a216ff4cd3RxCUI 238019, 748797, 748878, 748879
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 LEVORA 0.15/30-28 is indicated for use by females of reproductive potential to prevent pregnancy.
Excerpt only. Read the full label for complete information.
About NDC 51862-097
- What is NDC 51862-097?
- 51862-097 is the product NDC for Levora kit, listed with the FDA by Mayne Pharma Inc..
- What drug is associated with this NDC?
- Levora (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 Levora?
- 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.