Lopreeza
- Product NDC
- 69238-1252
- 11-digit product format
- 692381252
- Labeler code
- 69238
- Product ID
- 69238-1252_16c8c503-117a-47cf-9770-b7c5185e20cf
- 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 AUTHORIZED GENERIC
- Marketing start
- 2014-10-01
- Substance
- ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- .5; .1 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 | .5 mg/1 |
| NORETHINDRONE ACETATE | .1 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 |
|---|
| 69238-1252-6 | Lopreeza | 28 in 1 DIALPACK | TABLET, FILM COATED | 28 | | 19 |
| 69238-1252-6 | Lopreeza | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 19 |
| 69238-1252-8 | Lopreeza | 5 in 1 CELLO PACK | TABLET, FILM COATED | 5 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| NORETHINDRONE ACETATE | ACTIVE INGREDIENT | 9S44LIC7OJ | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| NORETHINDRONE | ACTIVE MOIETY | T18F433X4S | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| COPOVIDONE K25-31 | INACTIVE INGREDIENT | D9C330MD8B | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1252 | LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] | 19 | Current NDC, Legacy NDC, 3 package rows | 20231231_bf0e39cb-95e7-4831-92d2-0b3f071aeaae.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 |
|---|
| 69238-1252-6 | 69238125206 | 28 in 1 DIALPACK | | | | | | Historical |
| 69238-1252-8 | 69238125208 | 5 CARTON in 1 CELLO PACK (69238-1252-8) / 1 DIALPACK in 1 CARTON (69238-1252-6) / 28 TABLET, FILM COATED in 1 DIALPACK | 5 carton | 2014-10-01 | 0000-00-00 | No | No | Current |