lopreeza

Generic: estradiol/norethindrone acetate

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA 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 .5 mg/1, norethindrone acetate .1 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1609
Product ID 69238-1609_617a2d78-e850-4965-a23a-b0eacd0541a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020907
Listing Expiration 2026-12-31
Marketing Start 2019-01-07

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 692381609
Hyphenated Format 69238-1609

Supplemental Identifiers

RxCUI
1359123 1359124 1359126 1359127 1550964 1550965
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
  • .5 mg/1
  • .1 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (69238-1609-6) / 28 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

69238-1609-6 1 BLISTER PACK in 1 CARTON (69238-1609-6) / 28 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

estradiol (.5 mg/1) norethindrone acetate (.1 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": "617a2d78-e850-4965-a23a-b0eacd0541a1", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["9S44LIC7OJ", "4TI98Z838E"], "rxcui": ["1359123", "1359124", "1359126", "1359127", "1550964", "1550965"], "spl_set_id": ["966ac064-9eb7-4d15-b271-a7880ed1e79a"], "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": "1 BLISTER PACK in 1 CARTON (69238-1609-6)  / 28 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "69238-1609-6", "marketing_start_date": "20190107"}], "brand_name": "LOPREEZA", "product_id": "69238-1609_617a2d78-e850-4965-a23a-b0eacd0541a1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "69238-1609", "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": ".5 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".1 mg/1"}], "application_number": "NDA020907", "marketing_category": "NDA", "marketing_start_date": "20190107", "listing_expiration_date": "20261231"}