junel 21 day

Generic: norethindrone acetate and ethinyl estradiol

Labeler: teva pharmaceuticals usa, inc.
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 teva pharmaceuticals usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-9025
Product ID 0555-9025_254f2e35-bbeb-4134-8799-2d3fa959fe84
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 05559025
Hyphenated Format 0555-9025

Supplemental Identifiers

RxCUI
259176 1358762 1358763 1358765 1358776 1358780 1359022 1359023 1359025 1359028 1359030
UNII
9S44LIC7OJ 423D2T571U
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 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 (0555-9025-42) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0555-9025-42 3 POUCH in 1 CARTON (0555-9025-42) / 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, Junel Fe 28 Day ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "254f2e35-bbeb-4134-8799-2d3fa959fe84", "openfda": {"nui": ["N0000175825", "N0000000100"], "unii": ["9S44LIC7OJ", "423D2T571U"], "rxcui": ["259176", "1358762", "1358763", "1358765", "1358776", "1358780", "1359022", "1359023", "1359025", "1359028", "1359030"], "spl_set_id": ["8b82ad14-580c-4145-b825-dce849f95363"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (0555-9025-42)  / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK", "package_ndc": "0555-9025-42", "marketing_start_date": "20030918"}], "brand_name": "Junel 21 Day", "product_id": "0555-9025_254f2e35-bbeb-4134-8799-2d3fa959fe84", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0555-9025", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "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"}