Prescription drug · ANDA
Low-Ogestrel (Norgestrel and ethinyl estradiol) NDC 51862-564
Kit · Mayne Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51862-564-06 | 5186205640651862056406 | 6 BLISTER PACK in 1 CARTON (51862-564-06) / 1 KIT in 1 BLISTER PACK (51862-564-01)Marketed from Aug 3, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Low-Ogestrel
- Generic name (nonproprietary)
- norgestrel 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 075288
- Marketing start
- Marketing end
- Identifiers
- Product ID 51862-564_051f62cc-9a4a-40bc-9a9b-e7942354c0dcSPL ID 051f62cc-9a4a-40bc-9a9b-e7942354c0dcSPL set ID 8755b020-d439-4ba2-a60b-6c57a15ece55RxCUI 311359, 748797, 749786, 750244
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
N451862056406followed by a unit qualifier and the quantityPackage 51862-0564-06. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Low-Ogestrel is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15-40 years was approximately 1 pregnancy per 100 women-years of use.
Excerpt only. Read the full label for complete information.
About NDC 51862-564
- What is NDC 51862-564?
- 51862-564 is the product NDC for Low-Ogestrel kit, listed with the FDA by Mayne Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Low-Ogestrel (Norgestrel 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 Low-Ogestrel?
- 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.