junel fe 28 day

Generic: norethindrone acetate and ethinyl estradiol and ferrous fumarate

Labeler: pd-rx pharmaceuticals, 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 pd-rx pharmaceuticals, inc.
Dosage Form KIT
Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-450
Product ID 72789-450_341924b9-109f-cf3d-e063-6394a90a29c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076081
Listing Expiration 2026-12-31
Marketing Start 2003-09-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789450
Hyphenated Format 72789-450

Supplemental Identifiers

RxCUI
259176 1358762 1358763 1358765
UPC
0372789450797

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 ANDA076081 (source: ndc)

Resolved Composition

Strengths
  • 1 mg
  • 20 mcg
  • 75 mg
source: label
Packaging
  • 28 BLISTER PACK in 1 POUCH (72789-450-79) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"spl_id": "341924b9-109f-cf3d-e063-6394a90a29c0", "openfda": {"upc": ["0372789450797"], "rxcui": ["259176", "1358762", "1358763", "1358765"], "spl_set_id": ["93a2f8c9-3550-42ec-8f76-3ac9badf4bb2"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "28 BLISTER PACK in 1 POUCH (72789-450-79)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "72789-450-79", "marketing_start_date": "20241108"}], "brand_name": "Junel Fe 28 Day", "product_id": "72789-450_341924b9-109f-cf3d-e063-6394a90a29c0", "dosage_form": "KIT", "product_ndc": "72789-450", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Junel", "brand_name_suffix": "Fe 28 Day", "application_number": "ANDA076081", "marketing_category": "ANDA", "marketing_start_date": "20030918", "listing_expiration_date": "20261231"}