Prescription drug · NDA
Lopreeza (Estradiol/norethindrone acetate) NDC 69238-1609
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 |
|---|---|---|---|
| 69238-1609-6 | 6923816090669238160906 | 1 BLISTER PACK in 1 CARTON (69238-1609-6) / 28 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 7, 2019 |
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
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020907
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 69238-1609_617a2d78-e850-4965-a23a-b0eacd0541a1SPL ID 617a2d78-e850-4965-a23a-b0eacd0541a1SPL set ID 966ac064-9eb7-4d15-b271-a7880ed1e79aRxCUI 1359123, 1359124, 1359126, 1359127, 1550964, 1550965UNII 9S44LIC7OJ, 4TI98Z838E
- 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
N469238160906followed by a unit qualifier and the quantityPackage 69238-1609-06. 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 indicated for: Lopreeza is an estrogen and progestin combination indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2) Limitations of Use : When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. Prevention of Postmenopausal Osteoporosis (1.3) Limitations of Use : When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy…
Excerpt only. Read the full label for complete information.
About NDC 69238-1609
- What is NDC 69238-1609?
- 69238-1609 is the product NDC for Lopreeza (estradiol/norethindrone acetate), Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lopreeza (Estradiol/norethindrone acetate).
- What is the active ingredient?
- Estradiol, Norethindrone acetate.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lopreeza?
- 3 other product NDCs are listed under this name. See all Lopreeza NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lopreeza products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lopreezaestradiol/norethindrone acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1610 | 69238-1610-06 |
| Lopreezaestradiol/norethindrone acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1251 | 69238-1251-08 |
| Lopreezaestradiol/norethindrone acetate | Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1252 | 69238-1252-08 |
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 |
|---|---|---|---|---|
| Activellaestradiol/norethindrone acetate | Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 60846-231 |
| Activellaestradiol/norethindrone acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 60846-232 |
| Lopreezaestradiol/norethindrone acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1251 |
| Lopreezaestradiol/norethindrone acetate | Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1252 |
| Lopreezaestradiol/norethindrone acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1610 |