etyqa

Generic: estradiol and norethindrone acetate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etyqa
Generic Name estradiol and norethindrone acetate
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

estradiol 1 mg/1, norethindrone acetate .5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-424
Product ID 59651-424_50c8c596-e201-4370-8487-421925c60b4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214729
Listing Expiration 2026-12-31
Marketing Start 2023-06-30

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
estradiol congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651424
Hyphenated Format 59651-424

Supplemental Identifiers

RxCUI
1359123 1359124 1359126 1359127 2642136 2642137
UNII
9S44LIC7OJ 4TI98Z838E
NUI
M0447348 N0000175825 N0000000100

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name etyqa (source: ndc)
Generic Name estradiol and norethindrone acetate (source: ndc)
Application Number ANDA214729 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
  • .5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (59651-424-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 POUCH in 1 CARTON (59651-424-87) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

59651-424-28 1 BLISTER PACK in 1 CARTON (59651-424-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK 59651-424-87 1 POUCH in 1 CARTON (59651-424-87) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

estradiol (1 mg/1) norethindrone acetate (.5 mg/1)

Linked Drug Pages (1)

Etyqa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "50c8c596-e201-4370-8487-421925c60b4e", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["9S44LIC7OJ", "4TI98Z838E"], "rxcui": ["1359123", "1359124", "1359126", "1359127", "2642136", "2642137"], "spl_set_id": ["afbc2a33-5eb2-4f01-91e9-07d8050da6ce"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (59651-424-28)  / 28 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "59651-424-28", "marketing_start_date": "20230630"}, {"sample": false, "description": "1 POUCH in 1 CARTON (59651-424-87)  / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "59651-424-87", "marketing_start_date": "20230630"}], "brand_name": "Etyqa", "product_id": "59651-424_50c8c596-e201-4370-8487-421925c60b4e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "59651-424", "generic_name": "ESTRADIOL AND NORETHINDRONE ACETATE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etyqa", "active_ingredients": [{"name": "ESTRADIOL", "strength": "1 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".5 mg/1"}], "application_number": "ANDA214729", "marketing_category": "ANDA", "marketing_start_date": "20230630", "listing_expiration_date": "20261231"}