hailey 1.5/30

Generic: norethindrone acetate and ethinyl estradiol

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

Drug Facts

Product Profile

Brand Name hailey 1.5/30
Generic Name norethindrone acetate and ethinyl estradiol
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ethinyl estradiol .03 mg/1, norethindrone acetate 1.5 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-504
Product ID 68462-504_299fb286-ee60-4950-8315-d310c6ce29cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209297
Listing Expiration 2027-12-31
Marketing Start 2018-06-05

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 68462504
Hyphenated Format 68462-504

Supplemental Identifiers

RxCUI
1359022 1359028 2047760
UPC
0368462504819
UNII
423D2T571U 9S44LIC7OJ
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 hailey 1.5/30 (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol (source: ndc)
Application Number ANDA209297 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .03 mg/1
  • 1.5 mg/1
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (68462-504-81) / 1 BLISTER PACK in 1 POUCH (68462-504-79) / 21 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

68462-504-81 3 POUCH in 1 CARTON (68462-504-81) / 1 BLISTER PACK in 1 POUCH (68462-504-79) / 21 TABLET in 1 BLISTER PACK

Ingredients (2)

ethinyl estradiol (.03 mg/1) norethindrone acetate (1.5 mg/1)

Linked Drug Pages (1)

Hailey 1.5/30 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "299fb286-ee60-4950-8315-d310c6ce29cd", "openfda": {"nui": ["N0000175825", "N0000000100"], "upc": ["0368462504819"], "unii": ["423D2T571U", "9S44LIC7OJ"], "rxcui": ["1359022", "1359028", "2047760"], "spl_set_id": ["021df70a-0c37-4237-a2f7-2597ff6d41f5"], "pharm_class_epc": ["Estrogen [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 (68462-504-81)  / 1 BLISTER PACK in 1 POUCH (68462-504-79)  / 21 TABLET in 1 BLISTER PACK", "package_ndc": "68462-504-81", "marketing_start_date": "20180605"}], "brand_name": "Hailey 1.5/30", "product_id": "68462-504_299fb286-ee60-4950-8315-d310c6ce29cd", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "68462-504", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hailey 1.5/30", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": ".03 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": "1.5 mg/1"}], "application_number": "ANDA209297", "marketing_category": "ANDA", "marketing_start_date": "20180605", "listing_expiration_date": "20271231"}