Prescription drug · ANDA
Estradiol And Norethindrone Acetate NDC 79929-012
Norethindrone acetate .5 mg/1; Estradiol 1 mg/1 · Tablet · Oral · Naari Pte. Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 79929-012-07 | 79929001207 | 84 BLISTER PACK in 1 POUCH (79929-012-07) / 28 TABLET in 1 BLISTER PACKMarketed from Jun 11, 2024 |
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)
- Estradiol And Norethindrone Acetate
- Generic name (nonproprietary)
- estradiol and norethindrone acetate
- Active ingredients
- Norethindrone acetate — .5 mg/1Estradiol — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Naari Pte. Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210233
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 79929-012_1a990fcf-1731-8ca1-e063-6294a90ac9c8SPL ID 1a990fcf-1731-8ca1-e063-6294a90ac9c8SPL set ID f70185fe-9fcf-655f-e053-6394a90a20dcRxCUI 1359126, 1359127UNII 9S44LIC7OJ, 4TI98Z838EUPC 0379929012075
- 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
N479929001207followed by a unit qualifier and the quantityPackage 79929-0012-07. 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)
Estradiol and Norethindrone acetate tablets is indicated for: Estradiol and Norethindrone acetate tablet 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, firs…
Excerpt only. Read the full label for complete information.