NDC codes

FDA NDC Directory
Product 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.

Full label on DailyMed (opens in a new tab)

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.

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