Prescription drug · ANDA
Azurette NDC 51862-890
desogestrel/ethinyl estradiol and ethinyl estradiol · Kit · Mayne Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51862-890-01 | 51862089001 | 1 BLISTER PACK in 1 PACKET (51862-890-01) / 1 KIT in 1 BLISTER PACKMarketed from Oct 3, 2020 | |
| 51862-890-02 | 51862089002 | 1 BLISTER PACK in 1 CARTON (51862-890-02) / 1 KIT in 1 BLISTER PACKMarketed from Oct 3, 2020 | |
| 51862-890-03 | 51862089003 | 3 BLISTER PACK in 1 CARTON (51862-890-03) / 1 KIT in 1 BLISTER PACKMarketed from Oct 3, 2020 |
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)
- Azurette
- Generic name (nonproprietary)
- desogestrel/ethinyl estradiol and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Mayne Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091247
- Marketing start
- Listing expires
- Identifiers
- Product ID 51862-890_0f94b0b9-a7da-4030-9acf-542d6607d7fbSPL ID 0f94b0b9-a7da-4030-9acf-542d6607d7fbSPL set ID bff09a7b-aea6-460b-a263-44576e00f510RxCUI 248310, 249357, 748797, 759743, 831872
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
N451862089001followed by a unit qualifier and the quantityPackage 51862-0890-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Azurette (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is 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 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, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. TABLE II : Percentage of women experiencing an unintended pregnancy during the first year of …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091247
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.