Prescription drug · ANDA
Cyred EQ (Desogestrel and ethinyl estradiol) NDC 50102-254
Kit · Afaxys Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50102-254-23 | 5010202542350102025423 | 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, LLCNDC labeler code 50102
- 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.
About NDC 50102-254
- What is NDC 50102-254?
- 50102-254 is the product NDC for Cyred EQ kit, listed with the FDA by Afaxys Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cyred EQ (Desogestrel and Ethinyl Estradiol).
- Who is the labeler?
- Afaxys Pharma, LLC, NDC labeler code 50102. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cyred EQ?
- 1 other product NDC are listed under this name. See all Cyred EQ NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cyred EQ products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cyred EQdesogestrel and ethinyl estradiol | — | Kit | Bryant Ranch Prepack | 63629-5649 | — |
Other NDCs under ANDA 207081
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cyred EQdesogestrel and ethinyl estradiol | — | Kit | Bryant Ranch Prepack | 63629-5649 |
| Kalligadesogestrel and ethinyl estradiol | — | Kit | Aurobindo Pharma Limited | 65862-887 |