Prescription drug · ANDA
Alyacen 1/35 (Norethindrone and ethinyl estradiol) NDC 71205-547
Kit · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-547-28 | 71205054728 | 1 PACKAGE in 1 BAG (71205-547-28) / 1 KIT in 1 PACKAGEMarketed from Mar 25, 2021 |
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)
- Alyacen 1/35
- Generic name (nonproprietary)
- norethindrone and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091634
- Marketing start
- Listing expires
- Identifiers
- Product ID 71205-547_660c806f-2e79-4234-a83c-80224454e964SPL ID 660c806f-2e79-4234-a83c-80224454e964SPL set ID fa32e05b-c86d-4743-aee5-be3fc515152bRxCUI 312033, 748797, 749858, 1242786UPC 0371205547288
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
N471205054728followed by a unit qualifier and the quantityPackage 71205-0547-28. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE ALYACEN 1/35 Tabletsare 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 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 methods can result in lower failure rates. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of …
Excerpt only. Read the full label for complete information.
About NDC 71205-547
- What is NDC 71205-547?
- 71205-547 is the product NDC for Alyacen 1/35 kit, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alyacen 1/35 (Norethindrone and ethinyl estradiol).
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alyacen 1/35?
- 2 other product NDCs are listed under this name. See all Alyacen 1/35 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alyacen 1/35 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alyacen 1/35norethindrone and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-1477 | 50090-1477-00 |
| Alyacen 1/35norethindrone and ethinyl estradiol | — | Kit | Glenmark Pharmaceuticals Inc., USA | 68462-394 | 68462-0394-29 |
Other NDCs under ANDA 091634
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 |
|---|---|---|---|---|
| Alyacen 1/35norethindrone and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-1477 |
| Alyacen 1/35norethindrone and ethinyl estradiol | — | Kit | Glenmark Pharmaceuticals Inc., USA | 68462-394 |