norethindrone acetate and ethinyl estradiol and ferrous fumarate

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

Identifiers & Regulatory

Product NDC 0378-7303
Product ID 0378-7303_931f0bbe-68fa-5010-6d73-7f97e3d9eddf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205069
Listing Expiration 2026-12-31
Marketing Start 2022-07-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03787303
Hyphenated Format 0378-7303

Supplemental Identifiers

RxCUI
259176 1358762 1359130 1359131 1359132

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 and ferrous fumarate (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol and ferrous fumarate (source: ndc)
Application Number ANDA205069 (source: ndc)

Resolved Composition

Strengths
  • 1 mg
  • 20 mcg
  • 30 mcg
  • 35 mcg
  • 75 mg
source: label
Packaging
  • 3 POUCH in 1 CARTON (0378-7303-53) / 1 BLISTER PACK in 1 POUCH (0378-7303-85) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK (0378-7191-71) * 9 TABLET in 1 BLISTER PACK (0378-7192-59) * 7 TABLET in 1 BLISTER PACK (0378-7193-71) * 5 TABLET in 1 BLISTER PACK (0378-7190-98)
source: ndc

Packages (1)

0378-7303-53 3 POUCH in 1 CARTON (0378-7303-53) / 1 BLISTER PACK in 1 POUCH (0378-7303-85) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK (0378-7191-71) * 9 TABLET in 1 BLISTER PACK (0378-7192-59) * 7 TABLET in 1 BLISTER PACK (0378-7193-71) * 5 TABLET in 1 BLISTER PACK (0378-7190-98)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "931f0bbe-68fa-5010-6d73-7f97e3d9eddf", "openfda": {"rxcui": ["259176", "1358762", "1359130", "1359131", "1359132"], "spl_set_id": ["054917fa-573b-4b16-a719-ece6c0909656"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (0378-7303-53)  / 1 BLISTER PACK in 1 POUCH (0378-7303-85)  / 1 KIT in 1 BLISTER PACK *  7 TABLET in 1 BLISTER PACK (0378-7191-71)  *  9 TABLET in 1 BLISTER PACK (0378-7192-59)  *  7 TABLET in 1 BLISTER PACK (0378-7193-71)  *  5 TABLET in 1 BLISTER PACK (0378-7190-98)", "package_ndc": "0378-7303-53", "marketing_start_date": "20220727"}], "brand_name": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE", "product_id": "0378-7303_931f0bbe-68fa-5010-6d73-7f97e3d9eddf", "dosage_form": "KIT", "product_ndc": "0378-7303", "generic_name": "norethindrone acetate and ethinyl estradiol and ferrous fumarate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE", "application_number": "ANDA205069", "marketing_category": "ANDA", "marketing_start_date": "20220727", "listing_expiration_date": "20261231"}