dolishale
Generic: levonorgestrel and ethinyl estradiol
Labeler: ingenus pharmaceuticals, llcDrug Facts
Product Profile
Brand Name
dolishale
Generic Name
levonorgestrel and ethinyl estradiol
Labeler
ingenus pharmaceuticals, llc
Dosage Form
TABLET
Routes
Active Ingredients
ethinyl estradiol 20 ug/1, levonorgestrel 90 ug/1
Manufacturer
Identifiers & Regulatory
Product NDC
50742-659
Product ID
50742-659_514dd27c-d315-4775-91d2-a58ac2293edc
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA091692
Listing Expiration
2026-12-31
Marketing Start
2021-01-03
Pharmacologic Class
Established (EPC)
Mechanism of Action
Chemical Structure
Physiologic Effect
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
50742659
Hyphenated Format
50742-659
Supplemental Identifiers
RxCUI
UNII
NUI
Packaging Origin
Original Packager
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
dolishale (source: ndc)
Generic Name
levonorgestrel and ethinyl estradiol (source: ndc)
Application Number
ANDA091692 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 20 ug/1
- 90 ug/1
Packaging
- 1 BLISTER PACK in 1 CARTON (50742-659-28) / 28 TABLET in 1 BLISTER PACK
- 6 BLISTER PACK in 1 CARTON (50742-659-68) / 28 TABLET in 1 BLISTER PACK
- 3 BLISTER PACK in 1 CARTON (50742-659-84) / 28 TABLET in 1 BLISTER PACK
Packages (3)
Ingredients (2)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "514dd27c-d315-4775-91d2-a58ac2293edc", "openfda": {"nui": ["N0000175825", "N0000000100", "N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["423D2T571U", "5W7SIA7YZW"], "rxcui": ["722152", "751553", "2472307"], "spl_set_id": ["036a15be-8c2e-4f65-b5dc-f333e2994d4a"], "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": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50742-659-28) / 28 TABLET in 1 BLISTER PACK", "package_ndc": "50742-659-28", "marketing_start_date": "20210103"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (50742-659-68) / 28 TABLET in 1 BLISTER PACK", "package_ndc": "50742-659-68", "marketing_start_date": "20210103"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (50742-659-84) / 28 TABLET in 1 BLISTER PACK", "package_ndc": "50742-659-84", "marketing_start_date": "20210103"}], "brand_name": "Dolishale", "product_id": "50742-659_514dd27c-d315-4775-91d2-a58ac2293edc", "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": "50742-659", "generic_name": "Levonorgestrel and Ethinyl Estradiol", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dolishale", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "20 ug/1"}, {"name": "LEVONORGESTREL", "strength": "90 ug/1"}], "application_number": "ANDA091692", "marketing_category": "ANDA", "marketing_start_date": "20210103", "listing_expiration_date": "20261231"}