Fyavolv
- Product NDC
- 68180-828
- 11-digit product format
- 681800828
- Labeler code
- 68180
- Product ID
- 68180-828_42e98704-dee2-481c-849b-e3d9439a7005
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone Acetate and Ethinyl Estradiol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA204213
- Marketing category
- ANDA
- Marketing start
- 2016-03-15
- Substance
- ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- .005; 1 mg/1; mg/1
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fyavolv
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | .005 mg/1 |
| NORETHINDRONE ACETATE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 9S44LIC7OJ |
| Rxcui | 1090992, 1251323, 1736654, 1736656 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-828-09 | Fyavolv | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 18 |
| 68180-828-13 | Fyavolv | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 18 |
| 68180-828-13 | Fyavolv | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 18 |
| 68180-828-73 | Fyavolv | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 18 |
| 68180-828-73 | Fyavolv | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-828 | FYAVOLV (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 16 | Current NDC, Legacy NDC, 5 package rows | 20250524_772c86d7-10a4-48c5-8c19-f8aac68f5ab4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-828-09 | 68180082809 | 90 TABLET, FILM COATED in 1 BOTTLE (68180-828-09) | | 2016-03-15 | 2022-10-31 | No | No | Current |
| 68180-828-13 | 68180082813 | 3 POUCH in 1 CARTON (68180-828-13) > 1 BLISTER PACK in 1 POUCH (68180-828-11) > 28 TABLET, FILM COATED in 1 BLISTER PACK | 3 pouch | 2016-03-15 | 2022-01-31 | No | No | Current |
| 68180-828-73 | 68180082873 | 3 POUCH in 1 CARTON (68180-828-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK | 3 pouch | 2020-11-30 | 0000-00-00 | No | No | Current |