junel fe 28 day

Generic: norethindrone acetate and ethinyl estradiol and ferrous fumarate

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

Drug Facts

Product Profile

Brand Name junel fe 28 day
Generic Name norethindrone acetate and ethinyl estradiol and ferrous fumarate
Labeler teva pharmaceuticals usa, inc.
Dosage Form KIT
Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-9028
Product ID 0555-9028_254f2e35-bbeb-4134-8799-2d3fa959fe84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076064
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 05559028
Hyphenated Format 0555-9028

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 fe 28 day (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol and ferrous fumarate (source: ndc)
Application Number ANDA076064 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 1 mg
  • 20 mcg
  • 75 mg
  • 1.5 mg
  • 30 mcg
source: label
Packaging
  • 6 POUCH in 1 CARTON (0555-9028-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

0555-9028-58 6 POUCH in 1 CARTON (0555-9028-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

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 
{"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": "6 POUCH in 1 CARTON (0555-9028-58)  / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK", "package_ndc": "0555-9028-58", "marketing_start_date": "20030918"}], "brand_name": "Junel Fe 28 Day", "product_id": "0555-9028_254f2e35-bbeb-4134-8799-2d3fa959fe84", "dosage_form": "KIT", "product_ndc": "0555-9028", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Junel", "brand_name_suffix": "Fe 28 Day", "application_number": "ANDA076064", "marketing_category": "ANDA", "marketing_start_date": "20030918", "listing_expiration_date": "20261231"}