LOPREEZA
- Product NDC
- 69238-1610
- 11-digit product format
- 692381610
- Labeler code
- 69238
- Product ID
- 69238-1610_617a2d78-e850-4965-a23a-b0eacd0541a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol/norethindrone acetate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- NDA020907
- Marketing category
- NDA
- Marketing start
- 2019-01-07
- Substance
- ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- 1; .5 mg/1; mg/1
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LOPREEZA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | 1 mg/1 |
| NORETHINDRONE ACETATE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9S44LIC7OJ, 4TI98Z838E |
| Rxcui | 1359123, 1359124, 1359126, 1359127, 1550964, 1550965 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1610-6 | LOPREEZA | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 10 |
| 69238-1610-6 | LOPREEZA | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1610 | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250124_966ac064-9eb7-4d15-b271-a7880ed1e79a.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 |
|---|
| 69238-1610-6 | 69238161006 | 1 BLISTER PACK in 1 CARTON (69238-1610-6) / 28 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2019-01-07 | 0000-00-00 | No | No | Current |