junel 21 day

Generic: norethindrone acetate and ethinyl estradiol

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name junel 21 day
Generic Name norethindrone acetate and ethinyl estradiol
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ethinyl estradiol 20 ug/1, norethindrone acetate 1 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-172
Product ID 82804-172_56e91ad4-f31b-494d-9e75-6dd4f396779c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076380
Listing Expiration 2026-12-31
Marketing Start 2003-09-18

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 82804172
Hyphenated Format 82804-172

Supplemental Identifiers

RxCUI
1358762 1358776 1358780
UPC
0382804172214
UNII
423D2T571U 9S44LIC7OJ
NUI
N0000175825 N0000000100

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 junel 21 day (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol (source: ndc)
Application Number ANDA076380 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 ug/1
  • 1 mg/1
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (82804-172-21) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

82804-172-21 3 POUCH in 1 CARTON (82804-172-21) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK

Ingredients (2)

ethinyl estradiol (20 ug/1) norethindrone acetate (1 mg/1)

Linked Drug Pages (1)

Junel 21 Day ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "56e91ad4-f31b-494d-9e75-6dd4f396779c", "openfda": {"nui": ["N0000175825", "N0000000100"], "upc": ["0382804172214"], "unii": ["423D2T571U", "9S44LIC7OJ"], "rxcui": ["1358762", "1358776", "1358780"], "spl_set_id": ["56e91ad4-f31b-494d-9e75-6dd4f396779c"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (82804-172-21)  / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK", "package_ndc": "82804-172-21", "marketing_start_date": "20241206"}], "brand_name": "Junel 21 Day", "product_id": "82804-172_56e91ad4-f31b-494d-9e75-6dd4f396779c", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "82804-172", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Junel", "brand_name_suffix": "21 Day", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "20 ug/1"}, {"name": "NORETHINDRONE ACETATE", "strength": "1 mg/1"}], "application_number": "ANDA076380", "marketing_category": "ANDA", "marketing_start_date": "20030918", "listing_expiration_date": "20261231"}