Prescription drug · NDA AUTHORIZED GENERIC
Lopreeza (estradiol/norethindrone acetate) NDC 69238-1252
Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 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 DIALPACKMarketed from Oct 1, 2014 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Lopreeza
- Generic name (nonproprietary)
- estradiol/norethindrone acetate
- Active ingredients
- Estradiol — .5 mg/1Norethindrone acetate — .1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020907
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 69238-1252_16c8c503-117a-47cf-9770-b7c5185e20cfSPL ID 16c8c503-117a-47cf-9770-b7c5185e20cfSPL set ID bf0e39cb-95e7-4831-92d2-0b3f071aeaaeRxCUI 1359123, 1359124, 1359126, 1359127, 1550964, 1550965UNII 9S44LIC7OJ, 4TI98Z838EUPC 0369238125269, 0369238125160
- Pharmacologic class
- Estrogen; Progestin
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469238125208followed by a unit qualifier and the quantityPackage 69238-1252-08. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Lopreeza is an estrogen and progestin combination indicated in a woman with a uterus for: Lopreeza 1 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) Prevention of Postmenopausal Osteoporosis (1.3) Lopreeza 1 mg/0.5 mg is also indicated in a woman with a uterus for: Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitation of Use When prescribing solely for the treatment of moderate to sev…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020907
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lopreezaestradiol/norethindrone acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1251 |
| Activellaestradiol/norethindrone acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 60846-232 |
| Activellaestradiol/norethindrone acetate | Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 60846-231 |
| Lopreezaestradiol/norethindrone acetate | Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1609 |
| Lopreezaestradiol/norethindrone acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1610 |