Prescription drug · NDA
Activella (estradiol/norethindrone acetate) NDC 60846-232
Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60846-232-01 | 60846023201 | 1 BLISTER PACK in 1 CARTON (60846-232-01) / 28 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 1, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Activella
- Generic name (nonproprietary)
- estradiol/norethindrone acetate
- Active ingredients
- Estradiol — 1 mg/1Norethindrone acetate — .5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- 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 60846-232_ec312506-ea70-4aa1-8c07-0347fe956a57SPL ID ec312506-ea70-4aa1-8c07-0347fe956a57SPL set ID d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0RxCUI 1359123, 1359124, 1359125, 1359126, 1359127, 1359128UNII 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
N460846023201followed by a unit qualifier and the quantityPackage 60846-0232-01. 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)
Activella is indicated for: Activella 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 thera…
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 |
| Lopreezaestradiol/norethindrone acetate | Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1252 |
| 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 |