luizza 1/20

Generic: norethindrone acetate and ethinyl estradiol

Labeler: xiromed, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name luizza 1/20
Generic Name norethindrone acetate and ethinyl estradiol
Labeler xiromed, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ethinyl estradiol .02 mg/1, norethindrone acetate 1 mg/1

Manufacturer
Xiromed, LLC

Identifiers & Regulatory

Product NDC 70700-313
Product ID 70700-313_3624fac4-47aa-b3c7-e063-6394a90ae96c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202771
Listing Expiration 2026-12-31
Marketing Start 2025-01-29

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70700313
Hyphenated Format 70700-313

Supplemental Identifiers

RxCUI
1358762 1358776 2714657
UPC
0370700313794
UNII
423D2T571U 9S44LIC7OJ
NUI
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 luizza 1/20 (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol (source: ndc)
Application Number ANDA202771 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .02 mg/1
  • 1 mg/1
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (70700-313-79) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

70700-313-79 3 POUCH in 1 CARTON (70700-313-79) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK

Ingredients (2)

ethinyl estradiol (.02 mg/1) norethindrone acetate (1 mg/1)

Linked Drug Pages (1)

LUIZZA 1/20 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3624fac4-47aa-b3c7-e063-6394a90ae96c", "openfda": {"nui": ["N0000175825", "N0000000100"], "upc": ["0370700313794"], "unii": ["423D2T571U", "9S44LIC7OJ"], "rxcui": ["1358762", "1358776", "2714657"], "spl_set_id": ["88d90f33-1034-4d27-034f-11d9c441c9e7"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Xiromed, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (70700-313-79)  / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK", "package_ndc": "70700-313-79", "marketing_start_date": "20250129"}], "brand_name": "LUIZZA 1/20", "product_id": "70700-313_3624fac4-47aa-b3c7-e063-6394a90ae96c", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "70700-313", "generic_name": "norethindrone acetate and ethinyl estradiol", "labeler_name": "Xiromed, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LUIZZA 1/20", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": ".02 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": "1 mg/1"}], "application_number": "ANDA202771", "marketing_category": "ANDA", "marketing_start_date": "20250129", "listing_expiration_date": "20261231"}