Prescription drug · ANDA
Cyred EQ NDC 50102-254
desogestrel and ethinyl estradiol · Kit · Afaxys Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50102-254-23 | 50102025423 | 3 POUCH in 1 CARTON (50102-254-23) / 1 BLISTER PACK in 1 POUCH (50102-254-21) / 1 KIT in 1 BLISTER PACKMarketed from May 17, 2017 |
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)
- Cyred EQ
- Generic name (nonproprietary)
- desogestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Afaxys Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207081
- Marketing start
- Listing expires
- Identifiers
- Product ID 50102-254_9c923303-f770-44a5-ab6c-358aa68b25ffSPL ID 9c923303-f770-44a5-ab6c-358aa68b25ffSPL set ID 2417aee4-6838-4ea6-8e0d-3144f522310cRxCUI 240707, 748797, 749848, 1660690
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
N450102025423followed by a unit qualifier and the quantityPackage 50102-0254-23. 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 Cyred EQ ® tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Cyred EQ ® , 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This rep…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207081
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.