Package 0378-3340-53

Brand: xulane

Generic: norelgestromin and ethinyl estradiol
NDC Package

Package Facts

Identity

Package NDC 0378-3340-53
Digits Only 0378334053
Product NDC 0378-3340
Description

3 POUCH in 1 CARTON (0378-3340-53) / 1 PATCH in 1 POUCH (0378-3340-16) / 7 d in 1 PATCH

Marketing

Marketing Status
Marketed Since 2014-04-16
Brand xulane
Generic norelgestromin and ethinyl estradiol
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TRANSDERMAL"], "spl_id": "5cf2e689-da68-4a6a-8761-267a63244360", "openfda": {"nui": ["N0000175825", "N0000000100", "M0447349", "N0000175602"], "unii": ["423D2T571U", "R0TAY3X631"], "rxcui": ["1534809", "1536586"], "spl_set_id": ["f7848550-086a-43d8-8ae5-047f4b9e4382"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 POUCH in 1 CARTON (0378-3340-32)  / 1 PATCH in 1 POUCH (0378-3340-17)  / 7 d in 1 PATCH", "package_ndc": "0378-3340-32", "marketing_start_date": "20160613"}, {"sample": false, "description": "3 POUCH in 1 CARTON (0378-3340-53)  / 1 PATCH in 1 POUCH (0378-3340-16)  / 7 d in 1 PATCH", "package_ndc": "0378-3340-53", "marketing_start_date": "20140416"}], "brand_name": "XULANE", "product_id": "0378-3340_5cf2e689-da68-4a6a-8761-267a63244360", "dosage_form": "PATCH", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0378-3340", "generic_name": "norelgestromin and ethinyl estradiol", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XULANE", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "35 ug/d"}, {"name": "NORELGESTROMIN", "strength": "150 ug/d"}], "application_number": "ANDA200910", "marketing_category": "ANDA", "marketing_start_date": "20140416", "listing_expiration_date": "20261231"}