Prescription drug · ANDA
Etyqa (Estradiol and norethindrone acetate) NDC 59651-425
Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-425-28 | 5965104252859651042528 | 1 BLISTER PACK in 1 CARTON (59651-425-28) / 28 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 30, 2023 | |
| 59651-425-87 | 5965104258759651042587 | 1 POUCH in 1 CARTON (59651-425-87) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 30, 2023 |
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)
- Etyqa
- Generic name (nonproprietary)
- estradiol and norethindrone acetate
- Active ingredients
- Estradiol — .5 mg/1Norethindrone acetate — .1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214729
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 59651-425_50c8c596-e201-4370-8487-421925c60b4eSPL ID 50c8c596-e201-4370-8487-421925c60b4eSPL set ID afbc2a33-5eb2-4f01-91e9-07d8050da6ceRxCUI 1359123, 1359124, 1359126, 1359127, 2642136, 2642137UNII 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
N459651042528followed by a unit qualifier and the quantityPackage 59651-0425-28. 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)
Etyqa is indicated for: Etyqa 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 o…
Excerpt only. Read the full label for complete information.
About NDC 59651-425
- What is NDC 59651-425?
- 59651-425 is the product NDC for Etyqa, Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Etyqa (Estradiol and norethindrone acetate).
- What is the active ingredient?
- Estradiol, Norethindrone acetate.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Etyqa?
- 1 other product NDC are listed under this name. See all Etyqa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Etyqa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Etyqaestradiol and norethindrone acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-424 | 59651-0424-2859651-0424-87 |
Other NDCs under ANDA 214729
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 |
|---|---|---|---|---|
| Etyqaestradiol and norethindrone acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-424 |