YUVAFEM
- Product NDC
- 65162-226
- 11-digit product format
- 651620226
- Labeler code
- 65162
- Product ID
- 65162-226_b3543f3c-816d-46c4-b9e0-b706d4b1f425
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- TABLET
- Route
- VAGINAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA205256
- Marketing category
- ANDA
- Marketing start
- 2016-10-17
- Substance
- ESTRADIOL
- Active strength
- 10 ug/1
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- YUVAFEM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | 10 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E |
| Rxcui | 884707, 1797113 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | ESTRADIOL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | ESTRADIOL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ESTRADIOL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ESTRADIOL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESTRADIOL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ESTRADIOL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ESTRADIOL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-226 | YUVAFEM (ESTRADIOL) TABLET [AMNEAL PHARMACEUTICALS LLC] | 25 | Current NDC, Legacy NDC, 4 package rows | 20250108_30c7f6ba-7a9e-4853-b3e4-e00a46560224.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 |
|---|
| 65162-226-21 | 65162022621 | 8 APPLICATOR in 1 CARTON (65162-226-21) / 1 TABLET in 1 APPLICATOR | 8 applicator | 2016-10-17 | 0000-00-00 | No | No | Current |
| 65162-226-23 | 65162022623 | 18 APPLICATOR in 1 CARTON (65162-226-23) / 1 TABLET in 1 APPLICATOR | 18 applicator | 2016-10-17 | 0000-00-00 | No | No | Current |