levonorgestrel and ethinyl estradiol (68462-637)

Drug Facts

Product Profile

Brand Name levonorgestrel and ethinyl estradiol

Generic Name levonorgestrel and ethinyl estradiol

Labeler glenmark pharmaceuticals inc., usa

Dosage Form TABLET

Routes

ORAL

Active Ingredients

ethinyl estradiol 20 ug/1, levonorgestrel 90 ug/1

Manufacturer

Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-637

Product ID 68462-637_ed921f2c-7961-477a-bbac-2e666d32e3ba

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202791

Listing Expiration 2027-12-31

Marketing Start 2015-04-09

Pharmacologic Class

Established (EPC)

estrogen [epc] progestin [epc] progestin-containing intrauterine system [epc]

Mechanism of Action

estrogen receptor agonists [moa]

Chemical Structure

progesterone congeners [cs]

Physiologic Effect

inhibit ovum fertilization [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462637

Hyphenated Format 68462-637

Supplemental Identifiers

RxCUI

722152 751553

UPC

0368462637296 0368462637845

UNII

423D2T571U 5W7SIA7YZW

NUI

N0000175825 N0000000100 N0000175830 M0447349 N0000175602 N0000175832

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 levonorgestrel and ethinyl estradiol (source: ndc)

Generic Name levonorgestrel and ethinyl estradiol (source: ndc)

Application Number ANDA202791 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 ug/1
90 ug/1

source: ndc

Packaging

3 POUCH in 1 CARTON (68462-637-29) / 1 BLISTER PACK in 1 POUCH (68462-637-84) / 28 TABLET in 1 BLISTER PACK

source: ndc

Packages (1)

68462-637-29 3 POUCH in 1 CARTON (68462-637-29) / 1 BLISTER PACK in 1 POUCH (68462-637-84) / 28 TABLET in 1 BLISTER PACK

Ingredients (2)

ethinyl estradiol (20 ug/1) levonorgestrel (90 ug/1)

Linked Drug Pages (1)

Levonorgestrel and Ethinyl Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "ed921f2c-7961-477a-bbac-2e666d32e3ba", "openfda": {"nui": ["N0000175825", "N0000000100", "N0000175830", "M0447349", "N0000175602", "N0000175832"], "upc": ["0368462637296", "0368462637845"], "unii": ["423D2T571U", "5W7SIA7YZW"], "rxcui": ["722152", "751553"], "spl_set_id": ["44fbc5ae-5682-471f-a12a-955e8b4d233a"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_pe": ["Inhibit Ovum Fertilization [PE]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (68462-637-29)  / 1 BLISTER PACK in 1 POUCH (68462-637-84)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "68462-637-29", "marketing_start_date": "20150409"}], "brand_name": "Levonorgestrel and Ethinyl Estradiol", "product_id": "68462-637_ed921f2c-7961-477a-bbac-2e666d32e3ba", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "68462-637", "generic_name": "Levonorgestrel and Ethinyl Estradiol", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levonorgestrel and Ethinyl Estradiol", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "20 ug/1"}, {"name": "LEVONORGESTREL", "strength": "90 ug/1"}], "application_number": "ANDA202791", "marketing_category": "ANDA", "marketing_start_date": "20150409", "listing_expiration_date": "20271231"}