Prescription drug · NDA
Femlyv (norethindrone acetate/ethinyl estradiol) NDC 72495-601
Kit · Millicent US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72495-601-28 | 72495060128 | 1 POUCH in 1 CARTON (72495-601-28) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Nov 1, 2024 | |
| 72495-601-84 | 72495060184 | 3 POUCH in 1 CARTON (72495-601-84) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Nov 1, 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)
- Femlyv
- Generic name (nonproprietary)
- norethindrone acetate/ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Millicent US, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218718
- Marketing start
- Listing expires
- Identifiers
- Product ID 72495-601_5bfa2209-e9bb-4d9b-97cb-2f8cd0058178SPL ID 5bfa2209-e9bb-4d9b-97cb-2f8cd0058178SPL set ID a3c99fc1-9b05-4f0a-ad00-5e3e206302c9RxCUI 2696883, 2696886, 2696887, 2696888
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
N472495060128followed by a unit qualifier and the quantityPackage 72495-0601-28. 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)
FEMLYV is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] . Limitations of Use The efficacy of FEMLYV in females with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. FEMLYV is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy ( 1 ) Limitations of Use The efficacy in females of reproductive potential with a body mass index of more than 35 kg/m 2 has not been evaluated ( 1 , 8.8 )
Excerpt only. Read the full label for complete information.