junel fe

Generic: junel fe

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name junel fe
Generic Name junel fe
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-215
Product ID 72189-215_2be98712-5a86-2119-e063-6394a90ad71e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076380
Listing Expiration 2026-12-31
Marketing Start 2021-10-06

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 72189215
Hyphenated Format 72189-215

Supplemental Identifiers

RxCUI
1358762
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 fe (source: ndc)
Generic Name junel fe (source: ndc)
Application Number ANDA076380 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 ug/1
  • 1 mg/1
source: ndc
Packaging
  • 28 TABLET in 1 POUCH (72189-215-28)
source: ndc

Packages (1)

72189-215-28 28 TABLET in 1 POUCH (72189-215-28)

Ingredients (2)

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

Linked Drug Pages (1)

Junel FE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2be98712-5a86-2119-e063-6394a90ad71e", "openfda": {"nui": ["N0000175825", "N0000000100"], "unii": ["423D2T571U", "9S44LIC7OJ"], "rxcui": ["1358762"], "spl_set_id": ["ea62a66e-d45d-11be-e053-2a95a90a7801"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET in 1 POUCH (72189-215-28)", "package_ndc": "72189-215-28", "marketing_start_date": "20211006"}], "brand_name": "Junel FE", "product_id": "72189-215_2be98712-5a86-2119-e063-6394a90ad71e", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "72189-215", "generic_name": "Junel FE", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Junel FE", "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": "20211006", "listing_expiration_date": "20261231"}