norethindrone and ethinyl estradiol and ferrous fumarate

Generic: norethindrone and ethinyl estradiol and ferrous fumarate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norethindrone and ethinyl estradiol and ferrous fumarate
Generic Name norethindrone and ethinyl estradiol and ferrous fumarate
Labeler mylan pharmaceuticals inc.
Dosage Form KIT
Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-7297
Product ID 0378-7297_4805e8cc-2bd9-6f76-cb1f-2d818160ac24
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202086
Listing Expiration 2026-12-31
Marketing Start 2016-10-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03787297
Hyphenated Format 0378-7297

Supplemental Identifiers

RxCUI
433718 1095223 1095224

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 norethindrone and ethinyl estradiol and ferrous fumarate (source: ndc)
Generic Name norethindrone and ethinyl estradiol and ferrous fumarate (source: ndc)
Application Number ANDA202086 (source: ndc)

Resolved Composition

Strengths
  • 0.4 mg
  • 0.035 mg
  • 75 mg
source: label
Packaging
  • 3 POUCH in 1 CARTON (0378-7297-53) / 1 BLISTER PACK in 1 POUCH (0378-7297-85) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

0378-7297-53 3 POUCH in 1 CARTON (0378-7297-53) / 1 BLISTER PACK in 1 POUCH (0378-7297-85) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "4805e8cc-2bd9-6f76-cb1f-2d818160ac24", "openfda": {"rxcui": ["433718", "1095223", "1095224"], "spl_set_id": ["aabda044-9f17-4f1f-bb8d-2a78c9066fdc"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (0378-7297-53)  / 1 BLISTER PACK in 1 POUCH (0378-7297-85)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "0378-7297-53", "marketing_start_date": "20161028"}], "brand_name": "NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE", "product_id": "0378-7297_4805e8cc-2bd9-6f76-cb1f-2d818160ac24", "dosage_form": "KIT", "product_ndc": "0378-7297", "generic_name": "norethindrone and ethinyl estradiol and ferrous fumarate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE", "application_number": "ANDA202086", "marketing_category": "ANDA", "marketing_start_date": "20161028", "listing_expiration_date": "20261231"}