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
DailyMed Product Concepts#
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69238-1610-6 | EA - Each | 69238-1610 | 749e9dab-7571-42c4-b027-c69a044fe6a9 | 1 | 2019-05-02 |
DailyMed Dashboard NDC Coverage#
| 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#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1550964 | {28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack [Lopreeza 0.5/0.1 28 Day] | BPCK | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
| 1550965 | {28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } Pack [Lopreeza 1/0.5 28 Day] | BPCK | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
| 1359124 | {28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack | GPCK | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
| 1359127 | {28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } Pack | GPCK | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
| 1359124 | Estra-Noreth Ac 0.5-0.1 MG (28) Oral Tablet 28 Day Pack | PSN | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
| 1359127 | Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day Pack | PSN | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
| 1359123 | estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet | PSN | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
| 1359126 | estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet | PSN | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
| 1550964 | Lopreeza 0.5/0.1 28 Day Pack | PSN | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
| 1550965 | Lopreeza 1/0.5 28 Day Pack | PSN | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
| 1359123 | estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet | SCD | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
| 1359126 | estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet | SCD | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
| 1550964 | Lopreeza 0.5/0.1 28 Day Pack | SY | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
| 1550965 | Lopreeza 1/0.5 28 Day Pack | SY | 966ac064-9eb7-4d15-b271-a7880ed1e79a | 10 |
Packages#
| 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 |