Prescription drug · ANDA
Azurette NDC 75907-091
desogestrel/ethinyl estradiol and ethinyl estradiol · Kit · Dr. Reddys Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-091-28 | 75907009128 | 1 BLISTER PACK in 1 PACKET (75907-091-28) / 1 KIT in 1 BLISTER PACKMarketed from Jun 25, 2024 | |
| 75907-091-62 | 75907009162 | 6 BLISTER PACK in 1 CARTON (75907-091-62) / 1 KIT in 1 BLISTER PACKMarketed from Jun 25, 2024 |
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
- Dr. Reddys Laboratories Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091247
- Marketing start
- Listing expires
- Identifiers
- Product ID 75907-091_f64171dd-ac43-4be5-ba1d-51cbcff7991eSPL ID f64171dd-ac43-4be5-ba1d-51cbcff7991eSPL set ID f0288c8d-6ca0-41fa-93f2-b6c2d073891fRxCUI 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
N475907009128followed by a unit qualifier and the quantityPackage 75907-0091-28. 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 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 coosistent use of these methods can result in lower failure rates. Adapted from Hatcher et al., 1998, Ref#1. 1 Among typical couples who initiate use of a metho…
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.