lopreeza

Generic: estradiol/norethindrone acetate

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name lopreeza
Generic Name estradiol/norethindrone acetate
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1251
Product ID 69238-1251_16c8c503-117a-47cf-9770-b7c5185e20cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020907
Listing Expiration 2026-12-31
Marketing Start 2014-10-01

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 692381251
Hyphenated Format 69238-1251

Supplemental Identifiers

RxCUI
1359123 1359124 1359126 1359127 1550964 1550965
UPC
0369238125269 0369238125160
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 lopreeza (source: ndc)
Generic Name estradiol/norethindrone acetate (source: ndc)
Application Number NDA020907 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
  • .5 mg/1
source: ndc
Packaging
  • 5 CARTON in 1 CELLO PACK (69238-1251-8) / 1 DIALPACK in 1 CARTON (69238-1251-6) / 28 TABLET, FILM COATED in 1 DIALPACK
source: ndc

Packages (1)

69238-1251-8 5 CARTON in 1 CELLO PACK (69238-1251-8) / 1 DIALPACK in 1 CARTON (69238-1251-6) / 28 TABLET, FILM COATED in 1 DIALPACK

Ingredients (2)

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

Linked Drug Pages (1)

Lopreeza ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "16c8c503-117a-47cf-9770-b7c5185e20cf", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0369238125269", "0369238125160"], "unii": ["9S44LIC7OJ", "4TI98Z838E"], "rxcui": ["1359123", "1359124", "1359126", "1359127", "1550964", "1550965"], "spl_set_id": ["bf0e39cb-95e7-4831-92d2-0b3f071aeaae"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 CARTON in 1 CELLO PACK (69238-1251-8)  / 1 DIALPACK in 1 CARTON (69238-1251-6)  / 28 TABLET, FILM COATED in 1 DIALPACK", "package_ndc": "69238-1251-8", "marketing_start_date": "20141001"}], "brand_name": "Lopreeza", "product_id": "69238-1251_16c8c503-117a-47cf-9770-b7c5185e20cf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "69238-1251", "generic_name": "estradiol/norethindrone acetate", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lopreeza", "active_ingredients": [{"name": "ESTRADIOL", "strength": "1 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".5 mg/1"}], "application_number": "NDA020907", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20141001", "listing_expiration_date": "20261231"}