FEMLYV
- Product NDC
- 72495-601
- 11-digit product format
- 724950601
- Labeler code
- 72495
- Product ID
- 72495-601_5bfa2209-e9bb-4d9b-97cb-2f8cd0058178
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone Acetate/Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Millicent US, Inc.
- Application
- NDA218718
- Marketing category
- NDA
- Marketing start
- 2024-11-01
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FEMLYV
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 2696883, 2696886, 2696887, 2696888 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72495-601-28 | FEMLYV | 1 in 1 CARTON | KIT | 1 | 3 | |
| 72495-601-28 | FEMLYV | 1 in 1 POUCH | KIT | 1 | 3 | |
| 72495-601-84 | FEMLYV | 1 in 1 POUCH | KIT | 1 | 3 | |
| 72495-601-84 | FEMLYV | 3 in 1 CARTON | KIT | 3 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72495-601-28 | EA - Each | 72495-601 | ffaee21b-5a8e-4841-9b15-b1f30254f88a | 1 | 2024-10-04 |
| 72495-601-84 | EA - Each | 72495-601 | aa0e98f1-bdef-45ad-8aa3-a0e55cbafa0a | 1 | 2024-10-04 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2696888 | {24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral Tablet) / 4 (inert ingredients 1 MG Disintegrating Oral Tablet) } Pack [Femlyv 24 ODT 28 Day] | BPCK | a3c99fc1-9b05-4f0a-ad00-5e3e206302c9 | 3 |
| 2696887 | {24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral Tablet) / 4 (inert ingredients 1 MG Disintegrating Oral Tablet) } Pack | GPCK | a3c99fc1-9b05-4f0a-ad00-5e3e206302c9 | 3 |
| 2696883 | ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral Tablet | PSN | a3c99fc1-9b05-4f0a-ad00-5e3e206302c9 | 3 |
| 2696887 | ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral Tablet 28 Day Pack | PSN | a3c99fc1-9b05-4f0a-ad00-5e3e206302c9 | 3 |
| 2696888 | FEMLYV 24 ODT 28 Day Pack | PSN | a3c99fc1-9b05-4f0a-ad00-5e3e206302c9 | 3 |
| 2696886 | inert ingredients 1 MG Disintegrating Oral Tablet | PSN | a3c99fc1-9b05-4f0a-ad00-5e3e206302c9 | 3 |
| 2696883 | ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral Tablet | SCD | a3c99fc1-9b05-4f0a-ad00-5e3e206302c9 | 3 |
| 2696886 | inert ingredients 1 MG Disintegrating Oral Tablet | SCD | a3c99fc1-9b05-4f0a-ad00-5e3e206302c9 | 3 |
| 2696887 | ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral Tablet 28 Day Pack | SY | a3c99fc1-9b05-4f0a-ad00-5e3e206302c9 | 3 |
| 2696883 | ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Disintegrating Oral Tablet | SY | a3c99fc1-9b05-4f0a-ad00-5e3e206302c9 | 3 |
| 2696888 | Femlyv 24 ODT 28 Day Pack | SY | a3c99fc1-9b05-4f0a-ad00-5e3e206302c9 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72495-601-28 | 72495060128 | 1 POUCH in 1 CARTON (72495-601-28) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | 1 pouch | 2024-11-01 | No | No | Current |
| 72495-601-84 | 72495060184 | 3 POUCH in 1 CARTON (72495-601-84) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | 3 pouch | 2024-11-01 | No | No | Current |