mimvey

Generic: estradiol and norethindrone acetate

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

Drug Facts

Product Profile

Brand Name mimvey
Generic Name estradiol and norethindrone acetate
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-5455
Product ID 0093-5455_2704fcb9-da21-461e-b6ba-b196b2f2bf4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079193
Listing Expiration 2026-12-31
Marketing Start 2010-06-02

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 00935455
Hyphenated Format 0093-5455

Supplemental Identifiers

RxCUI
1359126 1359127 1359129
UNII
4TI98Z838E 9S44LIC7OJ
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 mimvey (source: ndc)
Generic Name estradiol and norethindrone acetate (source: ndc)
Application Number ANDA079193 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
  • .5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0093-5455-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK
  • 5 BLISTER PACK in 1 CARTON (0093-5455-42) / 28 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

0093-5455-28 1 BLISTER PACK in 1 CARTON (0093-5455-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK 0093-5455-42 5 BLISTER PACK in 1 CARTON (0093-5455-42) / 28 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Mimvey ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2704fcb9-da21-461e-b6ba-b196b2f2bf4b", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E", "9S44LIC7OJ"], "rxcui": ["1359126", "1359127", "1359129"], "spl_set_id": ["b1c5c06b-9ce2-4bf7-9693-e37608055a14"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0093-5455-28)  / 28 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0093-5455-28", "marketing_start_date": "20100602"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (0093-5455-42)  / 28 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0093-5455-42", "marketing_start_date": "20100602"}], "brand_name": "Mimvey", "product_id": "0093-5455_2704fcb9-da21-461e-b6ba-b196b2f2bf4b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0093-5455", "generic_name": "Estradiol and Norethindrone Acetate", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mimvey", "active_ingredients": [{"name": "ESTRADIOL", "strength": "1 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".5 mg/1"}], "application_number": "ANDA079193", "marketing_category": "ANDA", "marketing_start_date": "20100602", "listing_expiration_date": "20261231"}