norethindrone acetate and ethinyl estradiol

Generic: norethindrone acetate and ethinyl estradiol

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

Drug Facts

Product Profile

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

Identifiers & Regulatory

Product NDC 0378-7288
Product ID 0378-7288_ef1c54ca-92fb-677c-b2fe-46a2f872046a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202741
Listing Expiration 2026-12-31
Marketing Start 2019-12-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03787288
Hyphenated Format 0378-7288

Supplemental Identifiers

RxCUI
259176 1359022 1359023

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 acetate and ethinyl estradiol (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol (source: ndc)
Application Number ANDA202741 (source: ndc)

Resolved Composition

Strengths
  • 1.5 mg/0.03 mg
  • 75 mg
source: label
Packaging
  • 3 POUCH in 1 CARTON (0378-7288-53) / 1 BLISTER PACK in 1 POUCH (0378-7288-85) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

0378-7288-53 3 POUCH in 1 CARTON (0378-7288-53) / 1 BLISTER PACK in 1 POUCH (0378-7288-85) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "ef1c54ca-92fb-677c-b2fe-46a2f872046a", "openfda": {"rxcui": ["259176", "1359022", "1359023"], "spl_set_id": ["4423eebd-6397-4330-85a8-baa2e736767a"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (0378-7288-53)  / 1 BLISTER PACK in 1 POUCH (0378-7288-85)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "0378-7288-53", "marketing_start_date": "20191216"}], "brand_name": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL", "product_id": "0378-7288_ef1c54ca-92fb-677c-b2fe-46a2f872046a", "dosage_form": "KIT", "product_ndc": "0378-7288", "generic_name": "norethindrone acetate and ethinyl estradiol", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL", "application_number": "ANDA202741", "marketing_category": "ANDA", "marketing_start_date": "20191216", "listing_expiration_date": "20261231"}