fyavolv

Generic: norethindrone acetate and ethinyl estradiol

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fyavolv
Generic Name norethindrone acetate and ethinyl estradiol
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ethinyl estradiol .0025 mg/1, norethindrone acetate .5 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-827
Product ID 68180-827_42e98704-dee2-481c-849b-e3d9439a7005
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204213
Listing Expiration 2027-12-31
Marketing Start 2016-03-15

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 68180827
Hyphenated Format 68180-827

Supplemental Identifiers

RxCUI
1090992 1251323 1736654 1736656
UPC
0368180828099 0368180827092 0368180827719 0368180828716
UNII
9S44LIC7OJ 423D2T571U
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 fyavolv (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol (source: ndc)
Application Number ANDA204213 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .0025 mg/1
  • .5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (68180-827-09)
  • 3 POUCH in 1 CARTON (68180-827-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

68180-827-09 90 TABLET, FILM COATED in 1 BOTTLE (68180-827-09) 68180-827-73 3 POUCH in 1 CARTON (68180-827-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

ethinyl estradiol (.0025 mg/1) norethindrone acetate (.5 mg/1)

Linked Drug Pages (1)

Fyavolv ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42e98704-dee2-481c-849b-e3d9439a7005", "openfda": {"nui": ["N0000175825", "N0000000100"], "upc": ["0368180828099", "0368180827092", "0368180827719", "0368180828716"], "unii": ["9S44LIC7OJ", "423D2T571U"], "rxcui": ["1090992", "1251323", "1736654", "1736656"], "spl_set_id": ["772c86d7-10a4-48c5-8c19-f8aac68f5ab4"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68180-827-09)", "package_ndc": "68180-827-09", "marketing_start_date": "20160315"}, {"sample": false, "description": "3 POUCH in 1 CARTON (68180-827-73)  / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68180-827-73", "marketing_start_date": "20201130"}], "brand_name": "Fyavolv", "product_id": "68180-827_42e98704-dee2-481c-849b-e3d9439a7005", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "68180-827", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fyavolv", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": ".0025 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".5 mg/1"}], "application_number": "ANDA204213", "marketing_category": "ANDA", "marketing_start_date": "20160315", "listing_expiration_date": "20271231"}