etonogestrel and ethinyl estradiol

Generic: etonogestrel and ethinyl estradiol

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

Drug Facts

Product Profile

Brand Name etonogestrel and ethinyl estradiol
Generic Name etonogestrel and ethinyl estradiol
Labeler teva pharmaceuticals usa, inc.
Dosage Form INSERT, EXTENDED RELEASE
Routes
VAGINAL
Active Ingredients

ethinyl estradiol .015 mg/d, etonogestrel .12 mg/d

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-7679
Product ID 0093-7679_d0827dbf-9df5-4438-a0c2-92d7d593e71c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204305
Marketing Start 2021-01-19
Marketing End 2027-07-31

Pharmacologic Class

Established (EPC)
estrogen [epc] progestin [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
progesterone congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00937679
Hyphenated Format 0093-7679

Supplemental Identifiers

RxCUI
1367436
UPC
0300937679028
UNII
423D2T571U 304GTH6RNH
NUI
N0000175825 N0000000100 M0447349 N0000175602

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 etonogestrel and ethinyl estradiol (source: ndc)
Generic Name etonogestrel and ethinyl estradiol (source: ndc)
Application Number ANDA204305 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • .015 mg/d
  • .12 mg/d
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (0093-7679-02) / 21 d in 1 POUCH (0093-7679-01)
source: ndc

Packages (1)

0093-7679-02 3 POUCH in 1 CARTON (0093-7679-02) / 21 d in 1 POUCH (0093-7679-01)

Ingredients (2)

ethinyl estradiol (.015 mg/d) etonogestrel (.12 mg/d)

Linked Drug Pages (1)

Etonogestrel and Ethinyl Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "d0827dbf-9df5-4438-a0c2-92d7d593e71c", "openfda": {"nui": ["N0000175825", "N0000000100", "M0447349", "N0000175602"], "upc": ["0300937679028"], "unii": ["423D2T571U", "304GTH6RNH"], "rxcui": ["1367436"], "spl_set_id": ["a8cc104a-d522-49ad-af54-2f312b829b61"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (0093-7679-02)  / 21 d in 1 POUCH (0093-7679-01)", "package_ndc": "0093-7679-02", "marketing_end_date": "20270731", "marketing_start_date": "20210119"}], "brand_name": "Etonogestrel and Ethinyl Estradiol", "product_id": "0093-7679_d0827dbf-9df5-4438-a0c2-92d7d593e71c", "dosage_form": "INSERT, EXTENDED RELEASE", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0093-7679", "generic_name": "Etonogestrel and Ethinyl Estradiol", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etonogestrel and Ethinyl Estradiol", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": ".015 mg/d"}, {"name": "ETONOGESTREL", "strength": ".12 mg/d"}], "application_number": "ANDA204305", "marketing_category": "ANDA", "marketing_end_date": "20270731", "marketing_start_date": "20210119"}